prednisone and Glomerulosclerosis, Focal Segmental studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Glomerulosclerosis, Focal Segmental: A clinicopathological syndrome or diagnostic term for a type of glomerular injury that has multiple causes, primary or secondary. Clinical features include PROTEINURIA, reduced GLOMERULAR FILTRATION RATE, and EDEMA. Kidney biopsy initially indicates focal segmental glomerular consolidation (hyalinosis) or scarring which can progress to globally sclerotic glomeruli leading to eventual KIDNEY FAILURE.

Research Excerpts

Excerpt	Relevance	Reference
"Cyclosporine (CsA) is effective in treating steroid-dependent (SDNS) and steroid-resistant (SRNS) nephrotic syndrome (NS) in children, but because of the potential for chronic nephrotoxicity, its long-term use is controversial."	9.08	Long-term cyclosporine therapy for pediatric nephrotic syndrome: a clinical and histologic analysis. ( Bunchman, TE; Gregory, MJ; Johnson, K; Kershaw, DB; Sedman, A; Smoyer, WE; Valentini, RP, 1996)
"Twenty-eight patients with an onset of nephrotic syndrome within 1 year were randomized to receive either ciclosporin and low-dose prednisone or high-dose prednisone alone."	9.07	A randomized controlled trial of low-dose prednisone and ciclosporin versus high-dose prednisone in nephrotic syndrome of children. ( Pomrantz, A; Suthanthiran, M; Tejani, A, 1991)
"Prednisone-resistant nephrotic syndrome (NS) due to focal segmental glomerulosclerosis (FSGS), the most common acquired disease requiring chronic dialysis and transplantation in children, has a low likelihood of response to alkylating agent therapy."	7.69	Intravenous methylprednisolone and oral alkylating agent therapy of prednisone-resistant pediatric focal segmental glomerulosclerosis: a long-term follow-up. ( Griswold, WR; Kirpekar, R; Mendoza, SA; Reznik, VM; Sibley, RK; Tune, BM, 1995)
"Treatment with a combination of pulse methylprednisolone (MP) and an alkylating agent has been reported to induce long-term remission of proteinuria in patients with steroid-resistant nephrotic syndrome (SRNS)."	7.68	Methylprednisolone treatment of patients with steroid-resistant nephrotic syndrome. ( Benfield, MR; Kohaut, EC; Waldo, FB, 1992)
"Patients with prednisone-resistant nephrotic syndrome and biopsy-proven focal segmental glomerulosclerosis were treated with intravenous methylprednisone."	7.67	Treatment of childhood prednisone-resistant nephrotic syndrome and focal segmental glomerulosclerosis with intravenous methylprednisolone and oral alkylating agents. ( Brock, P; Griswold, WR; Mendoza, SA; Prime, DJ; Reznik, VM; Tune, BM; Vazquez, M, 1987)
"Mechlorethamine has been assessed in 28 patients with idiopathic nephrotic syndrome previously treated with prednisone only."	7.67	[Effect of mechlorethamine in idiopathic nephrotic syndrome in childhood]. ( Canals, MJ; Cervera, A; Gómez Campderá, FJ; Gómez Campderá, J; López Gómez, JM; Luque, A; Morales, JL, 1984)
" Beginning from the second LDL-A course, a dosage of 1 mg/kg/d of prednisone was administered for 6 weeks, then tapered."	6.71	A combined low-density lipoprotein apheresis and prednisone therapy for steroid-resistant primary focal segmental glomerulosclerosis in children. ( Akioka, Y; Chikamoto, H; Fukazawa, A; Hattori, M; Ito, K; Kawaguchi, H; Khono, M; Matsunaga, A; Miyakawa, S; Nakakura, H; Ogino, D, 2003)
"A 24-year-old woman with focal segmental glomerulosclerosis was referred to our hospital for treatment of nephrotic syndrome."	5.35	Oral mizoribine pulse therapy for steroid-dependent focal segmental glomerulosclerosis. ( Doi, T; Kawai, T; Masaki, T; Shiraki, N; Yorioka, N, 2008)
"Nephrotic syndrome secondary to focal segmental glomerulosclerosis (FSGS) is a common cause of renal failure leading to transplantation."	5.29	Effects of cyclosporine, azathioprine and prednisone on Kimura's disease and focal segmental glomerulosclerosis in renal transplant patients. ( Barcenas, C; Etheridge, WB; Jammal, C; Kahan, BD; Senel, MF; Van Buren, CT, 1996)
"Prednisone is the initial treatment of primary focal segmental glomerulosclerosis."	5.11	Cyclophosphamide in the treatment of focal segmental glomerulosclerosis. ( Martinelli, R; Okumura, AS; Pereira, LJ; Rocha, H; Silva, OM, 2004)
"Cyclosporine (CsA) is effective in treating steroid-dependent (SDNS) and steroid-resistant (SRNS) nephrotic syndrome (NS) in children, but because of the potential for chronic nephrotoxicity, its long-term use is controversial."	5.08	Long-term cyclosporine therapy for pediatric nephrotic syndrome: a clinical and histologic analysis. ( Bunchman, TE; Gregory, MJ; Johnson, K; Kershaw, DB; Sedman, A; Smoyer, WE; Valentini, RP, 1996)
"Twenty-eight patients with an onset of nephrotic syndrome within 1 year were randomized to receive either ciclosporin and low-dose prednisone or high-dose prednisone alone."	5.07	A randomized controlled trial of low-dose prednisone and ciclosporin versus high-dose prednisone in nephrotic syndrome of children. ( Pomrantz, A; Suthanthiran, M; Tejani, A, 1991)
" For instance, in patients with idiopathic membranous glomerulonephritis a six months treatment with chlorambucil (0."	5.05	[Drug treatment of chronic glomerulonephritis: pro]. ( Brodehl, J; Helmchen, U; Koch, KM; Kühn, K, 1985)
"In patient who develops ibandronate-associated CFSGS, proteinuria appears to be at least partially reversible with the treatment of prednisone and/or tacrolimus if the syndrome is recognized early and ibandronate is stopped."	4.91	Collapsing focal segmental glomerulosclerosis following long-term treatment with oral ibandronate: case report and review of literature. ( Cormack, FC; Gralow, JR; Jia, N; Najafian, B; Shiue, Z; Xie, B, 2015)
"The role of the multidrug resistance-1 (MDR1 or ABCB1) gene polymorphisms 1236T>C, 2677T>G, and 3435T>C was studied in relation to susceptibility, demographics, and pathological characteristics, as well as their role in the therapeutic response (TR) to prednisone treatment in children with idiopathic nephrotic syndrome (INS)."	3.81	MDR1 polymorphisms and idiopathic nephrotic syndrome in Slovak children: preliminary results. ( Boor, A; Cizmarikova, M; Habalova, V; Klimcakova, L; Mirossay, L; Mojzis, J; Podracka, L, 2015)
"Prednisone is a mainstay of treatment for patients with focal segmental glomerulosclerosis (FSGS), a disease characterized by reduced podocyte number and glomerulosclerosis."	3.79	Podocyte repopulation by renal progenitor cells following glucocorticoids treatment in experimental FSGS. ( Krofft, RD; Liu, ZH; Naito, S; Pippin, JW; Shankland, SJ; Zhang, J, 2013)
"Prednisone-resistant nephrotic syndrome (NS) due to focal segmental glomerulosclerosis (FSGS), the most common acquired disease requiring chronic dialysis and transplantation in children, has a low likelihood of response to alkylating agent therapy."	3.69	Intravenous methylprednisolone and oral alkylating agent therapy of prednisone-resistant pediatric focal segmental glomerulosclerosis: a long-term follow-up. ( Griswold, WR; Kirpekar, R; Mendoza, SA; Reznik, VM; Sibley, RK; Tune, BM, 1995)
"Seven children with steroid-resistant focal segmental glomerulosclerosis (SR-FGS) were placed on a therapeutic protocol of methylprednisolone (MP), oral prednisone (pred) and oral cyclophosphamide (CYC) given over 16 months (regimen A)."	3.69	Intensive pulse therapies for focal glomerulosclerosis in South African children. ( Adhikari, M; Bhimma, R; Coovadia, HM, 1997)
"Treatment with a combination of pulse methylprednisolone (MP) and an alkylating agent has been reported to induce long-term remission of proteinuria in patients with steroid-resistant nephrotic syndrome (SRNS)."	3.68	Methylprednisolone treatment of patients with steroid-resistant nephrotic syndrome. ( Benfield, MR; Kohaut, EC; Waldo, FB, 1992)
"Mechlorethamine has been assessed in 28 patients with idiopathic nephrotic syndrome previously treated with prednisone only."	3.67	[Effect of mechlorethamine in idiopathic nephrotic syndrome in childhood]. ( Canals, MJ; Cervera, A; Gómez Campderá, FJ; Gómez Campderá, J; López Gómez, JM; Luque, A; Morales, JL, 1984)
"Patients with prednisone-resistant nephrotic syndrome and biopsy-proven focal segmental glomerulosclerosis were treated with intravenous methylprednisone."	3.67	Treatment of childhood prednisone-resistant nephrotic syndrome and focal segmental glomerulosclerosis with intravenous methylprednisolone and oral alkylating agents. ( Brock, P; Griswold, WR; Mendoza, SA; Prime, DJ; Reznik, VM; Tune, BM; Vazquez, M, 1987)
"Nine cases of nephrotic children associated with focal segmental glomerulosclerosis who had failed to respond to prednisone and cyclophosphamide therapy and showed sign of progressive deterioration of renal function, were subjected to the therapeutic combinations of antiplatelet agents + prednisone +/- anticoagulant agents."	3.66	A new therapeutic approach of nephrotic syndrome associated with focal segmental glomerulosclerosis. ( Futrakul, P, 1980)
"Focal segmental glomerulosclerosis was proven by a kidney biopsy, and a hemizygous pathogenic variant located in the TBC (Tre-2-Bub2-Cdc16) domain of TBC1D8B was detected by whole-exome sequencing."	3.01	Adult-Onset Focal Segmental Glomerulosclerosis With Steroid-Dependent Nephrotic Syndrome Caused by a Novel TBC1D8B Variant: A Case Report and Literature Review. ( Cai, Y; Du, W; Fang, Z; Hao, X; Jin, Y; Liu, J; Pan, X; Ren, H; Tong, J; Weng, Q; Xie, J; Yang, L; Yu, S; Zhang, C; Zheng, Q, 2023)
" Beginning from the second LDL-A course, a dosage of 1 mg/kg/d of prednisone was administered for 6 weeks, then tapered."	2.71	A combined low-density lipoprotein apheresis and prednisone therapy for steroid-resistant primary focal segmental glomerulosclerosis in children. ( Akioka, Y; Chikamoto, H; Fukazawa, A; Hattori, M; Ito, K; Kawaguchi, H; Khono, M; Matsunaga, A; Miyakawa, S; Nakakura, H; Ogino, D, 2003)
"Idiopathic focal segmental glomerulosclerosis (FSGS) is an infrequent renal biopsy diagnosis in the elderly."	2.67	Steroid therapy and prognosis of focal segmental glomerulosclerosis in the elderly. ( Cattran, DC; Nagai, R; Pei, Y, 1994)
"Of these, collapsing focal segmental glomerulosclerosis (cFSGS) is the most rarely seen."	2.61	Collapsing Focal Segmental Glomerulosclerosis with Acute Interstitial Nephritis Associated with Plasmodium Falciparum: A Case Report and Review of the Literature. ( Alasadi, L; Azhar, M; Kemnele, S; Reiser, IW; Spitalewitz, S, 2019)
"Membranous nephropathy, focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) are the most common causes of idiopathic nephrotic syndrome."	2.50	B cell suppression in primary glomerular disease. ( Deegens, JK; Hofstra, JM; Rood, IM; Wetzels, JF, 2014)
"Nephrotic patients with primary focal segmental glomerulosclerosis (FSGS) have a poor prognosis with 50% progressing to end stage renal disease (ESRD) over 3 to 8 years."	2.41	The treatment of primary focal segmental glomerulosclerosis. ( Korbet, SM, 2000)
" Long-term use may be required to maintain remission (grade D)."	2.40	Management of focal segmental glomerulosclerosis: evidence-based recommendations. ( Burgess, E, 1999)
"There is no definite treatment for focal glomerulosclerosis."	2.38	Treatment of the nephrotic syndrome with cyclosporin A. ( Ponticelli, C, 1992)
" Therefore, intravenous high-dose steroid pulses, alternate-day prednisone, short courses with cytotoxic agents and long-term administration of azathioprine have been suggested as alternatives to the classical prolonged corticotherapy."	2.38	Conventional treatment of idiopathic nephrotic syndrome and membranous nephropathy in adults. ( Passerini, P; Ponticelli, C, 1991)
"Gender, age, and hypertension are associated with KD recurrence."	1.43	Clinicopathological features and prognosis of Kimura's disease with renal involvement in Chinese patients. ( Chen, Y; Liu, Z; Wang, J; Xu, F; Zeng, C, 2016)
"Nephrotic syndrome recurrence after kidney transplantation (in three patients with focal segmental glomerulosclerosis) was not accompanied by recurrent hypothyroidism."	1.38	Hypothyroidism in children with steroid-resistant nephrotic syndrome. ( Blumenthal, D; Cleper, R; Dagan, A; Davidovits, M; Krause, I, 2012)
"A 24-year-old woman with focal segmental glomerulosclerosis was referred to our hospital for treatment of nephrotic syndrome."	1.35	Oral mizoribine pulse therapy for steroid-dependent focal segmental glomerulosclerosis. ( Doi, T; Kawai, T; Masaki, T; Shiraki, N; Yorioka, N, 2008)
"During CsA treatment severe headaches and pains in orbits with nausea appeared."	1.35	[Neurological symptoms in patient with focal segmental glomerulosclerosis treated with cyclosporin A--case report]. ( Kuźma-Mroczkowska, E; Pańczyk-Tomaszewska, M; Roszkowska-Blaim, M, 2009)
"The diagnosis of Wegener's granulomatosis was based on the association of positive antineutrophil cytoplasmic antibodies, urinary sediment abnormalities and renal biopsy findings."	1.35	[Pulmonary fibrosis as a presentation of Wegener's granulomatosis]. ( Abid, T; Ayoub, A; Boudawara, T; Gharsalli, H; Kammoun, K; Ketata, W; Makni, S; Mrabet, S; Msaad, S, 2009)
"Oral prednisone was given concurrently at 60 mg/m2 daily for 6 weeks and then 40 mg/m2 on alternate days for 4 weeks."	1.33	Intravenous pulse cyclophosphamide therapy in focal segmental glomerulosclerosis. ( Anarat, A; Bayazit, AK; Buyukcelik, M; Cengiz, N; Dursun, H; Noyan, A; Soran, M, 2006)
"Sirolimus was used in association with mycofenolate mofetil and prednisone."	1.32	[Calcineurin-inhibitor-free immunosuppression in early renal transplantation]. ( Escuín, F; García de Miguel, A; Jiménez, C; Olea, T; Ros, S; Sanz, A, 2004)
"Prednisone was maintained at the adequate doses with tapering after 8 weeks and cyclosporine was given to achieve trough serum levels of 100-200 ng/mL."	1.32	A case of focal segmental glomerulosclerosis associated with aplastic anemia. ( Cho, YS; Chung, CH; Chung, JH; Kim, DM; Kim, HL; Park, CY; Yoon, SH, 2004)
"The oedema was not explained by immobility, hypoproteinaemia or local factors."	1.31	Chronic inflammatory demyelinating polyradiculoneuropathy and severe peripheral oedema: a renal explanation. ( Healy, HG; Henderson, RD; Lander, CM; McCombe, PA, 2000)
"Eighty nephrotic adults with focal segmental glomerulosclerosis (FSGS) and plasma creatinine lower than 3 mg/dL were given corticosteroids (53 patients) or immunosuppressive agents (27 patients) for a median of 16 and 75 weeks, respectively."	1.30	Can prolonged treatment improve the prognosis in adults with focal segmental glomerulosclerosis? ( Banfi, G; Baroli, A; Cesana, B; Farina, M; Grassi, C; Pani, A; Passerini, P; Ponticelli, C; Pozzi, C; Villa, M, 1999)
"In primary minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS), increased lymphocyte reactivity to renal antigens has been defined."	1.30	Urinary soluble HLA class I antigen in patients with minimal change disease: a predictor of steroid response. ( Ahn, SJ; Bang, BK; Chang, YS; Choi, EJ; Kim, SY; Kim, YS; Park, CW; Shin, YS; Song, HC, 1998)
"We report the case of a patient with acquired immunodeficiency syndrome (AIDS) who developed nephrotic syndrome and progressive renal failure mimicking human immunodeficiency virus (HIV)-associated focal segmental glomerulosclerosis (FSGS) who required initiation of hemodialysis and was found on renal biopsy to have membranous nephropathy."	1.30	AIDS-associated membranous nephropathy with advanced renal failure: response to prednisone. ( Ahuja, TS; Gooneratne, R; Mattana, J; Molho, L; Sankaran, RT; Schwarzwald, E; Siegal, FP; Singhal, PC, 1997)
"Nephrotic syndrome secondary to focal segmental glomerulosclerosis (FSGS) is a common cause of renal failure leading to transplantation."	1.29	Effects of cyclosporine, azathioprine and prednisone on Kimura's disease and focal segmental glomerulosclerosis in renal transplant patients. ( Barcenas, C; Etheridge, WB; Jammal, C; Kahan, BD; Senel, MF; Van Buren, CT, 1996)
"Renal biopsy was consistent with focal segmental glomerulosclerosis."	1.29	A case of Guillain-Barré syndrome with focal segmental glomerulosclerosis. ( Axelsen, R; Boyle, R; Careless, D; Rigby, R, 1993)
"End-stage renal disease (ESRD) was secondary to chronic glomerulonephritis (n = 9), diabetes mellitus (n = 6), polycystic kidney disease (n = 5), and miscellaneous causes (n = 11)."	1.28	The development of proteinuria and focal-segmental glomerulosclerosis in recipients of pediatric donor kidneys. ( Hayes, JM; Novick, AC; Steinmuller, DR; Streem, SB, 1991)
"A young man with focal glomerulosclerosis and severe steroid resistant nephrotic syndrome was treated with oral cyclosporin for six months without histological evidence of drug induced nephrotoxicity."	1.28	Cyclosporin therapy for steroid resistant nephrotic focal glomerulosclerosis. ( Fisher, M; Neale, TJ; Windom, HH, 1990)
"The significance of the finding of focal glomerulosclerosis (FGS) in idiopathic membranous glomerulonephritis (MGN) is uncertain."	1.28	Focal glomerulosclerosis in idiopathic membranous glomerulonephritis. ( Magil, AB; Wakai, S, 1992)
"Although this lesion resembles focal segmental glomerulosclerosis (FSGS), Howie and Brewer suggested that it constitutes a distinct entity, differing also clinically from FSGS, in that it would have a better response to steroid treatment."	1.27	The glomerular tip lesion: a distinct entity or not? ( Hené, RJ; Huppes, W; Kooiker, CJ, 1988)
"Focal segmental glomerulosclerosis was diagnosed by strict histologic criteria in 103 patients."	1.27	Evidence suggesting under-treatment in adults with idiopathic focal segmental glomerulosclerosis. Regional Glomerulonephritis Registry Study. ( Cattran, D; Delmore, T; Katz, A; Lang, A; Pei, Y; Rance, P, 1987)
"The incidence of CRF or ESRD in patients with a partial response to cyclophosphamide (1 of 9) was significantly lower (p = 0."	1.27	Response to cyclophosphamide in steroid-resistant focal segmental glomerulosclerosis: a reappraisal. ( Baumal, R; Farine, M; Geary, DF; Thorner, P, 1984)
"The frequency of chronic renal failure and ESRD has been similar in groups A and B."	1.27	Focal segmental glomerulosclerosis in children with idiopathic nephrotic syndrome. A report of the Southwest Pediatric Nephrology Study Group. ( , 1985)
"This case shows that relapse of Hodgkin's disease may occur after a 10 year interval and furthermore it may preceded by nephrotic syndrome."	1.27	Glomerulonephritis preceding late relapse of Hodgkin's disease. ( Lynn, WA; Marcus, RE, 1988)

Research

Studies (120)

Authors

Clinical Trials (22)

Trial Overview

Trial Outcomes

Number of Participants With Adverse Events

Timeframe	Studies, this research(%)	All Research%
pre-1990	40 (33.33)	18.7374
1990's	33 (27.50)	18.2507
2000's	24 (20.00)	29.6817
2010's	21 (17.50)	24.3611
2020's	2 (1.67)	2.80

Authors	Studies
Hodson, EM	1
Sinha, A	1
Cooper, TE	1
Fang, Z	1
Zhang, C	1
Jin, Y	1
Tong, J	1
Liu, J	1
Hao, X	1
Weng, Q	1
Yu, S	1
Du, W	1
Cai, Y	1
Zheng, Q	1
Yang, L	1
Ren, H	1
Pan, X	1
Xie, J	1
Azhar, M	1
Alasadi, L	1
Kemnele, S	1
Reiser, IW	1
Spitalewitz, S	1
Wang, H	1
Zheng, C	2
Xu, X	1
Zhao, Y	1
Lu, Y	1
Liu, Z	3
Bakhiet, YM	1
Mudi, A	1
Khumalo, T	1
Moonsamy, G	1
Levy, C	1
Koratala, A	1
Kazory, A	1
Li, J	1
Wang, L	1
Wan, L	1
Lin, T	1
Zhao, W	1
Cui, H	1
Li, H	1
Cao, L	1
Wu, J	1
Zhang, T	1
Zhang, J	1
Pippin, JW	1
Krofft, RD	1
Naito, S	1
Liu, ZH	1
Shankland, SJ	1
Borrego-Utiel, FJ	1
Pérez-del Barrio, Mdel P	1
Polaina-Rusillo, M	1
Borrego-Hinojosa, J	1
Fervenza, FC	1
Perazella, MA	1
Choi, MJ	1
Rood, IM	1
Hofstra, JM	1
Deegens, JK	3
Wetzels, JF	3
Li, F	1
Zhong, Y	1
Zeng, C	2
Xu, F	2
Yin, R	1
Jiang, Q	1
Zhou, M	1
Meijers, B	1
Sprangers, B	1
Cizmarikova, M	1
Podracka, L	1
Klimcakova, L	1
Habalova, V	1
Boor, A	1
Mojzis, J	1
Mirossay, L	1
Jia, N	1
Cormack, FC	1
Xie, B	1
Shiue, Z	1
Najafian, B	1
Gralow, JR	1
Scemla, A	1
Charlier, C	1
Noel, LH	1
Amazzough, K	1
Von Rosen, FT	1
Lesavre, P	1
Lortholary, O	1
Chen, Y	1
Wang, J	1
Zhu, TH	1
Rodriguez, PG	1
Behan, JW	1
Declerck, B	1
Kim, GH	1
Doi, T	1
Masaki, T	1
Shiraki, N	1
Kawai, T	1
Yorioka, N	1
Braun, N	1
Schmutzler, F	1
Lange, C	1
Perna, A	1
Remuzzi, G	1
Risler, T	1
Willis, NS	1
Kuźma-Mroczkowska, E	1
Pańczyk-Tomaszewska, M	1
Roszkowska-Blaim, M	1
Ketata, W	1
Msaad, S	1
Gharsalli, H	1
Kammoun, K	1
Abid, T	1
Mrabet, S	1
Makni, S	1
Boudawara, T	1
Ayoub, A	1
Gellermann, J	1
Stefanidis, CJ	1
Mitsioni, A	1
Querfeld, U	1
Jafry, N	1
Ahmed, E	1
Mubarak, M	1
Kazi, J	1
Akhter, F	1
Dagan, A	1
Cleper, R	1
Krause, I	1
Blumenthal, D	1
Davidovits, M	1
D'Agati, VD	1
Kaskel, FJ	1
Falk, RJ	1
Roncone, D	1
Rovin, B	1
Falk, R	1
Nicely, C	1
Nadasdy, T	1
Parikh, S	1
Hebert, LA	1
Montané, B	1
Abitbol, C	1
Chandar, J	1
Strauss, J	1
Zilleruelo, G	1
Hattori, M	1
Chikamoto, H	1
Akioka, Y	1
Nakakura, H	1
Ogino, D	1
Matsunaga, A	1
Fukazawa, A	1
Miyakawa, S	1
Khono, M	1
Kawaguchi, H	1
Ito, K	1
Olea, T	1
Jiménez, C	1
Escuín, F	1
García de Miguel, A	1
Ros, S	1
Sanz, A	1
Manrique, J	1
Rossich, E	1
Hernández Sierra, A	1
Rubio, E	1
Acevedo, M	1
Martinelli, R	2
Pereira, LJ	2
Silva, OM	1
Okumura, AS	2
Rocha, H	2
Bhatia, M	1
Kher, K	1
Minniti, CP	1
Tsugawa, K	1
Tanaka, H	1
Nakahata, T	1
Ito, E	1
Park, CY	1
Kim, DM	1
Cho, YS	1
Yoon, SH	1
Chung, JH	1
Chung, CH	1
Kim, HL	1
Dingli, D	1
Larson, DR	1
Plevak, MF	1
Grande, JP	1
Kyle, RA	1
Bodaghi, E	1
Chamsa, AM	1
Buyukcelik, M	1
Cengiz, N	1
Dursun, H	1
Soran, M	1
Bayazit, AK	1
Noyan, A	1
Anarat, A	1
Grcevska, L	1
Dzikova, S	1
Petrusevska, G	1
Polenakovic, M	1
Shatat, IF	1
Schoeneman, M	1
Flynn, JT	1
Woroniecki, RP	1
Barratt, TM	1
Geary, DF	2
Ponticelli, C	5
Banfi, G	3
Imbasciati, E	1
Tarantino, A	1
Cuoghi, D	1
Vangelista, A	1
Baraldi, A	1
Cheli, E	1
Tejani, A	2
Nicastri, AD	1
Sen, D	1
Chen, CK	1
Phadke, K	1
Adamson, O	1
Butt, KM	1
Parfrey, PS	1
Gómez Campderá, FJ	1
López Gómez, JM	1
Cervera, A	1
Gómez Campderá, J	1
Canals, MJ	1
Morales, JL	1
Luque, A	1
Farine, M	1
Thorner, P	1
Baumal, R	1
Tabin, R	1
Guignard, JP	1
Gautier, E	1
Dubrit, M	1
Jeannet, M	1
Golaz, J	1
Moretta, L	1
Olavarria, F	1
Caorsi, I	1
Arriagada, A	1
Mezzano, S	1
Figueroa, C	1
Quarre, JP	1
Ligny, G	1
Lardinois, J	1
Dehout, F	1
Meunier, R	1
Mongeau, JG	1
Corneille, L	1
Robitaille, P	1
O'Regan, S	1
Pelletier, M	1
McEnery, PT	1
Strife, CF	1
Nash, MA	1
Bakare, MA	1
D'Agati, V	1
Pirani, CL	1
Donadio, JV	1
Lau, J	1
Levey, AS	1
Kassirer, JP	1
Pauker, SG	1
Futrakul, P	1
Kohaut, EC	3
Edwards, GA	1
Hill, LL	1
Rosenberg, HS	1
Hartley, MW	1
Rydel, JJ	1
Korbet, SM	3
Borok, RZ	1
Schwartz, MM	2
Tune, BM	4
Kirpekar, R	1
Sibley, RK	1
Reznik, VM	2
Griswold, WR	2
Mendoza, SA	4
Nagai, R	1
Cattran, DC	2
Pei, Y	2
Almeida, MP	1
Almeida, HA	1
Rosa, FC	2
Careless, D	1
Rigby, R	1
Axelsen, R	1
Boyle, R	1
Senel, MF	1
Van Buren, CT	1
Etheridge, WB	1
Barcenas, C	1
Jammal, C	1
Kahan, BD	1
Sa, GA	1
Luis, JP	1
Mendonca, E	1
Almeida, M	1
Gregory, MJ	1
Smoyer, WE	1
Sedman, A	1
Kershaw, DB	1
Valentini, RP	1
Johnson, K	1
Bunchman, TE	1
Bakir, AA	1
Share, DS	1
Levy, PS	1
Arruda, JA	1
Dunea, G	1
Mattana, J	1
Siegal, FP	1
Schwarzwald, E	1
Molho, L	1
Sankaran, RT	1
Gooneratne, R	1
Ahuja, TS	1
Singhal, PC	1
Adhikari, M	1
Bhimma, R	1
Coovadia, HM	1
Park, CW	1
Song, HC	1
Shin, YS	1
Ahn, SJ	1
Kim, YS	1
Kim, SY	1
Choi, EJ	1
Chang, YS	1
Bang, BK	1
Rao, P	1
Waldo, FB	2
Benfield, MR	2
Feld, SM	1
Figueroa, P	1
Savin, V	1
Nast, CC	1
Sharma, R	1
Sharma, M	1
Hirschberg, R	1
Adler, SG	1
Bargman, JM	1
Burgess, E	1
Evans, J	1
Bain, R	1
Villa, M	1
Cesana, B	1
Pozzi, C	1
Pani, A	1
Passerini, P	2
Farina, M	1
Grassi, C	1
Baroli, A	1
Singh, HK	1
Baldree, LA	1
McKenney, DW	1
Hogan, SL	1
Jennette, JC	1
Henderson, RD	1
Healy, HG	1
McCombe, PA	1
Lander, CM	1
Stein, DF	1
Ahmed, A	1
Sunkhara, V	1
Khalbuss, W	1
Simon, NM	1
Rosenberg, MJ	1
Beirne, GJ	1
Wagnild, JP	1
Zimmerman, SW	1
Macken, PD	1
Burkholder, PM	1
Cameron, JS	1
Turner, DR	1
Ogg, CS	1
Chantler, C	1
Williams, DG	1
Gluckman, JC	1
Jacob, N	1
Beaufils, H	1
Baumelou, A	1
Salah, H	1
German, A	1
Legrain, M	1
Vázquez Tadei, G	1
Fernández, J	1
Martin Malo, A	1
Campdera, FG	1
Sanz Guajardo, D	1
Traver, JA	1
Botella, J	1
Schoeneman, MJ	1
Bennett, B	1
Greifer, I	1
Ellis, D	1
Kapur, S	1
Antonovych, TT	1
Salcedo, JR	1
Yunis, EJ	1
Baldwin, DS	1
Gluck, MC	1
Lowenstein, J	1
Gallo, GR	1
Wakai, S	1
Magil, AB	1
Tufro-McReddie, A	1
Alvarez, E	1
Arrizurieta, E	1
Repetto, H	1
McCauley, J	1
Tzakis, AG	1
Fung, JJ	1
Todo, S	1
Starzl, TE	1
Chan, PC	1
Chan, KW	1
Cheng, IK	1
Chan, MK	1
Meyrier, A	1
Condamin, MC	1
Broneer, D	1
Moriggi, M	1
Sabadini, E	1
Fellin, G	1
D'Amico, G	1
Suthanthiran, M	1
Pomrantz, A	1
Hayes, JM	1
Steinmuller, DR	1
Streem, SB	1
Novick, AC	1
Windom, HH	1
Fisher, M	1
Neale, TJ	1
Klinger, M	1
Szewczyk, Z	1
Andal, A	1
Saxena, S	1
Chellani, HK	1
Sharma, S	1
Brodehl, J	3
Hoyer, PF	2
Schulman, SL	1
Kaiser, BA	1
Polinsky, MS	1
Srinivasan, R	1
Baluarte, HJ	1
Lynn, WA	1
Marcus, RE	1
Brandis, M	1
Helmchen, U	2
Burghard, R	1
Ehrich, JH	1
Zimmerhackl, RB	1
Klein, W	1
Wonigeit, K	1
Huppes, W	1
Hené, RJ	1
Kooiker, CJ	1
Sinn, W	1
Ratner, M	1
Tomilina, N	1
Klinkmann, H	1
Nizze, H	1
Cattran, D	1
Delmore, T	1
Katz, A	1
Lang, A	1
Rance, P	1
Vazquez, M	1
Prime, DJ	1
Brock, P	1
Kühn, K	1
Koch, KM	1
Srivastava, RN	1
Agarwal, RK	1
Moudgil, A	1
Bhuyan, UN	1
White, RH	1
Glasgow, EF	1
Mills, RJ	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)[NCT02633046]	Phase 4	63 participants (Actual)	Interventional	2016-10-10	Completed
Focal Segmental Glomerulosclerosis Clinical Trial[NCT00135811]	Phase 3	207 participants (Anticipated)	Interventional	2004-11-30	Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)[NCT00404833]	Phase 3	16 participants (Anticipated)	Interventional	2003-01-31	Completed
Novel Therapies for Resistant FSGS[NCT00193648]	Phase 1	21 participants (Actual)	Interventional	2005-07-31	Completed
Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis[NCT00801463]		67 participants (Actual)	Interventional	2009-01-31	Completed
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental[NCT00302536]		0 participants (Actual)	Interventional	2006-03-31	Withdrawn (stopped due to There was less patients recruited.)
Pulse Dexamethasone Over 48 Weeks for Podocyte Disease[NCT00065611]	Phase 3	8 participants (Actual)	Interventional	2003-07-31	Completed
A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)[NCT02592798]	Phase 2	36 participants (Actual)	Interventional	2016-03-09	Completed
A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis[NCT01665391]	Phase 2	36 participants (Actual)	Interventional	2012-08-31	Completed
Novel Therapies for Resistant Focal Segmental Glomerulosclerosis[NCT00814255]	Phase 2	32 participants (Actual)	Interventional	2008-12-31	Completed
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis[NCT00956059]		40 participants (Anticipated)	Interventional	2009-09-30	Not yet recruiting
Efficacy and Safety of RE-021, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study[NCT01613118]	Phase 2	109 participants (Actual)	Interventional	2014-03-31	Active, not recruiting
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)[NCT03536754]	Phase 2	46 participants (Actual)	Interventional	2018-05-17	Completed
A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving Irbesartan[NCT03649152]	Phase 2	8 participants (Actual)	Interventional	2018-11-08	Completed
A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis[NCT01451489]		70 participants (Actual)	Interventional	2011-10-13	Terminated (stopped due to The recruitment of subject is very difficult)
A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS[NCT03493685]	Phase 3	371 participants (Actual)	Interventional	2018-04-17	Active, not recruiting
Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose Prednisone[NCT03298698]	Phase 3	40 participants (Anticipated)	Interventional	2018-08-22	Recruiting
Predictors of Disease Progression in Patients With Primary Focal Segmental Glomerulosclerosis[NCT03126201]		86 participants (Actual)	Observational	2016-12-31	Completed
Ofatumumab in Children With Steroid- and Calcineurin-inhibitor-resistant Nephrotic Syndrome: a Double-blind Randomized, Controlled, Superiority Trial[NCT02394106]	Phase 2	13 participants (Actual)	Interventional	2015-07-31	Terminated
Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor-dependent Idiopathic Nephrotic Syndrome: an Open-label, Randomized, Controlled, Superiority Trial.[NCT02394119]	Phase 2	140 participants (Actual)	Interventional	2015-06-30	Completed
Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System[NCT02235857]		35 participants (Anticipated)	Interventional	2015-05-03	Recruiting
Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy[NCT00001212]	Phase 2	45 participants	Interventional	1986-11-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with:~death for any reason (all cause mortality)~treatment emergent serious adverse events (TESAEs)~any non-serious treatment emergent adverse events (TEAEs)" (NCT02633046)
Timeframe: within 56 weeks

CKD-EPI eGFR

Intervention	Participants (Count of Participants)
	Deaths	Serious TEAEs	Non-serious TEAEs
Acthar Gel	0	11	60

Estimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula. (NCT00065611)
Timeframe: 48 weeks from baseline

Urine Protein

Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks

Intervention	ml/min/1.73m^2 (Mean)
2 Doses Every 2 Weeks Arm	60
4 Doses Every 4 Weeks Arm	73

Intervention	g/d (Mean)
2 Doses Every 2 Weeks Arm	3.6
4 Doses Every 4 Weeks Arm	6.2

Complete remission is defined as proteinuria <0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria <3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as >60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response. (NCT00065611)
Timeframe: 48 weeks from baseline

Area Under the Serum Concentration Time Curve Over a Dosing Interval (AUC(TAU)) of Abatacept

Maximum Observed Serum Concentration (Cmax) of Abatacept

Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Adult Participants

Intervention	participants (Number)
	Limited response	Non-response	Partial remission	Complete remission
2 Doses Every 2 Weeks Arm	1	2	1	0
4 Doses Every 4 Weeks Arm	1	1	1	0

Intervention	ug*h/mL (Geometric Mean)
	Adult participants	Pediatric participants
Abatacept	20394.83	18282.50

Intervention	ug/mL (Geometric Mean)
	Adult participants	Pediatric participants
Abatacept	200.46	174.65

"PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:~Fatigue: Short From (SF) Fatigue v1.0 Adult 8a, composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).~Pain Interference: SF Pain Interference v1.0 Adult 8a, (measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).~Physical Function: SF Physical Function v1.2 Adult 8b, composed of 8 questions, each one scored from 1 (Without any difficulty) to 5 (Unable to do). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome)." (NCT02592798)
Timeframe: From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period

Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Pediatric Participants

Intervention	Score on a scale (Mean)
	Fatigue	Pain Interference	Physical Function
Abatacept	-5.56	-4.88	0.78
Placebo	-4.87	-1.18	1.77

"PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:~Fatigue: Short From (SF) Fatigue v1.0 Peds 10a, composed of 10 questions, each one scored from 0 (Never) to 4 (Almost Always). Output presented as Total score, ranging from 0 (most desirable outcome) to 40 (least desirable outcome).~Pain Interference: SF Pain Interference v1.0 Peds 8a, ( measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 0 (Never) to 4 (Almost always). Output presented as Total score, ranging from 0 (most desirable outcome) to 32 (least desirable outcome).~Mobility: SF Physical Function-Mobility v1.0 Peds 8a, composed of 8 questions, each one scored from 0 (Not able to do) to 4 (With no trouble). Output presented as Total score, ranging from 0 (least desirable outcome) to 32 (most desirable outcome)." (NCT02592798)
Timeframe: From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period

Mean Change From Baseline in Serum Albumine at Day 113

Intervention	Score on a scale (Mean)
	Fatigue	Pain Interference	Mobility
Abatacept	6.43	5.70	0.80
Placebo	-6.02	-1.44	1.68

(NCT02592798)
Timeframe: From baseline (measured at day 1 of the study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)

Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113

Intervention	g/dL (Mean)
	Double-Blind Period Day 113	Open Label Period Day 113
Abatacept	0.08	0.21
Placebo	-0.05	0.09

(NCT02592798)
Timeframe: From baseline (measured at day 1 of study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)

Minimum Blood Plasma Concentration (Cmin) of Abatacept - Adult Participants

Intervention	mg/mg (Mean)
	Double-Blind Period Day 113	Open Label Period Day 113
Abatacept	0.12	1.98
Placebo	-0.25	0.02

(NCT02592798)
Timeframe: From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113

Minimum Blood Plasma Concentration (Cmin) of Abatacept - Pediatric Participants

Intervention	ug/mL (Geometric Mean)
	Day 15	Day 29	Day 57	Day 85	Day 113
Abatacept	7.613	12.274	3.641	4.101	2.786

(NCT02592798)
Timeframe: From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113

Number of Participants Experiencing Adverse Events

Intervention	ug/mL (Geometric Mean)
	Day 15	Day 29	Day 57	Day 85	Day 113
Abatacept	2.829	2.588	0.504	1.617	0.990

"This outcome describes the number of participants experiencing various types of any grade Adverse Events (AEs).~The Cumulative Abatacept Safety Period starts at the time of the first dose of Abatacept (either in the Double-Blind Period or in the Open Label Period) and lasts 56 days after the last dose of Abatacept" (NCT02592798)
Timeframe: From first dose in the indicated period to 56 days following last dose in the indicated period (169 days for the Double-Blind Period, up to 337 days for the Cumulative Abatacept Safety Period)

Number of Participants Experiencing Adverse Events of Special Interest

Intervention	Participants (Count of Participants)
	Adverse Events (AEs)	Serious Adverse Events (SAEs)	AEs leading to discontinuation	Deaths
Abatacept During Cumulative Abatacept Safety Period	26	10	2	0
Abatacept During Double-Blind Period	13	5	1	0
Placebo During Double-Blind Period	15	4	2	0

Number of participants experiencing various types of Adverse Events of interest, including infections, malignancies, autoimmune disorders, and infusional related reactions. (NCT02592798)
Timeframe: From first dose on day 1 to 56 days following last dose (approximately 330 days)

Percentage of Participants Achieving Complete Remission at Day 113

Intervention	Participants (Count of Participants)
	Peri-infusional Adverse Event (AE)	AE within 24 hours of Infusion	Malignancies	Infections/Infestations	Autoimmune disorders
Abatacept	6	8	0	12	0
Placebo	3	9	0	10	1

"Complete Remission is defined as the presence of all the following criteria:~PROTEINURIA: Urine protein/creatinine ratio (UPCR) ≤ 0.3. RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline." (NCT02592798)
Timeframe: From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)

Percentage of Participants in Renal Response at Day 113

Intervention	Percent of Participants (Number)
	Double-Blind Period Day 113	Open Label Period Day 113
Abatacept	0.0	12.5
Placebo	0.0	11.1

"Renal Response is defined as the presence of all the following criteria:~PROTEINURIA: Reduction of baseline urine protein/creatinine ratio (UPCR) of >= 50% and to less than 3.~RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline." (NCT02592798)
Timeframe: From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)

Percentage of Participants With Positive Antibody Response Relative to Baseline

Intervention	Percent of Participants (Number)
	Double-Blind Period Day 113	Open Label Period Day 113
Abatacept	0.0	12.5
Placebo	7.7	33.3

"A positive response relative to baseline is defined as a positive response at a post-baseline visit that has a titer value greater than the positive baseline titer value. If the baseline titer is missing or negative, any post-baseline positive titer value is considered a positive response relative to baseline.~Immunogenicity response is presented as the total of immunogenicity response for CTLA4 and possibly Ig and Ig and/or Junction Region." (NCT02592798)
Timeframe: From baseline (day 1) to 168 days following last dose (up to 15 months). Results at day 113 from first dose, day 56, day 84 and day 168 after last dose are presented

Time to Reach Peak Serum Concentration (Tmax(h)) of Abatacept

Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients

Intervention	Percent of Participants (Number)
	Day 113 from first dose	Day 56 from last dose	Day 84 from last dose	Day 168 from last dose
Abatacept	7.1	40.0	28.6	16.7
Placebo	0.0	66.7	66.7	25.0

Intervention	Hours (Mean)
	Adult participants	Pediatric participants
Abatacept	0.883	0.589

Number of participants with a reduction in proteinuria at 6 months by > 50% of the value at screening AND stable GFR defined as greater than 75 ml/min/1.73m2 in those with an initial value above 90 OR within 25% of baseline for remaining patients. (NCT00814255)
Timeframe: baseline and 6 months

Number of Participants With Adverse Events

Percent Change in Urine Protein/Creatinine (Up/C)

Intervention	participants (Number)
Conservative Medical Therapy Plus Adalimumab	0
Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	2
Conservative Medical Therapy Plus Galactose	2

Intervention	participants (Number)
Conservative Medical Therapy Plus Adalimumab	7
Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat	7
Conservative Medical Therapy Plus Galactose	7

Primary efficacy objective is to determine the change in Up/C in FSGS patients receiving RE-021 (Sparsentan) over a range of dose levels compared to treatment with irbesartan as active control. (NCT01613118)
Timeframe: 8 weeks

Change From Baseline in Basophils

Intervention	percent change (Geometric Least Squares Mean)
RE-021 (Sparsentan) 200, 400, 800 mg Pooled	-44.8
Irbesartan 300 mg Pooled	-18.5
RE-021 (Sparsentan) 200mg	-33.1
RE-021 (Sparsentan) 400mg	-52.7
RE-021 (Sparsentan) 800mg	-41.3

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Basophils/Leukocytes

Intervention	cells x 10^9/L (Mean)
Placebo	0.02
CCX140-B 5 mg Once Daily	0.03
CCX140-B 10 mg Twice Daily	0.02
CCX140-B 15 mg Twice Daily	-0.03
Open-label Extension	0.02

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Eosinophils

Intervention	percentage of basophils in leukocytes (Mean)
Placebo	0.08
CCX140-B 5 mg Once Daily	-0.01
CCX140-B 10 mg Twice Daily	0.18
CCX140-B 15 mg Twice Daily	-0.13
Open-label Extension	0.16

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Eosinophils/Leukocytes

Intervention	cells x 10^9/L (Mean)
Placebo	0.01
CCX140-B 5 mg Once Daily	0.01
CCX140-B 10 mg Twice Daily	0.00
CCX140-B 15 mg Twice Daily	0.01
Open-label Extension	0.03

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin

Intervention	percentage of Eosinophils in Leukocytes (Mean)
Placebo	0.32
CCX140-B 5 mg Once Daily	0.09
CCX140-B 10 mg Twice Daily	-0.02
CCX140-B 15 mg Twice Daily	0.33
Open-label Extension	0.27

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration

Intervention	picogram(s) (Mean)
Placebo	-0.2
CCX140-B 5 mg Once Daily	-0.3
CCX140-B 10 mg Twice Daily	-0.5
CCX140-B 15 mg Twice Daily	0.0
Open-label Extension	-0.1

HGB - Hemoglobin (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Erythrocyte Mean Corpuscular Volume

Intervention	g/dL (Mean)
Placebo	-0.20
CCX140-B 5 mg Once Daily	-0.18
CCX140-B 10 mg Twice Daily	-0.24
CCX140-B 15 mg Twice Daily	-0.16
Open-label Extension	-0.28

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Erythrocytes

Intervention	fL (Mean)
Placebo	-0.21
CCX140-B 5 mg Once Daily	-0.02
CCX140-B 10 mg Twice Daily	-0.33
CCX140-B 15 mg Twice Daily	0.03
Open-label Extension	0.44

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Hematocrit

Intervention	cells x 10^12/L (Mean)
Placebo	-0.004
CCX140-B 5 mg Once Daily	0.055
CCX140-B 10 mg Twice Daily	0.010
CCX140-B 15 mg Twice Daily	-0.55
Open-label Extension	-0.003

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Hemoglobin

Intervention	percentage of red blood cells in blood (Mean)
Placebo	-0.3
CCX140-B 5 mg Once Daily	0.5
CCX140-B 10 mg Twice Daily	-0.1
CCX140-B 15 mg Twice Daily	-0.8
Open-label Extension	0.2

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Lactate Dehydrogenase

Intervention	g/dL (Mean)
Placebo	-0.12
CCX140-B 5 mg Once Daily	0.13
CCX140-B 10 mg Twice Daily	-0.10
CCX140-B 15 mg Twice Daily	-0.25
Open-label Extension	-0.07

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Leukocytes

Intervention	U/L (Mean)
Placebo	-10.2
CCX140-B 5 mg Once Daily	-26.4
CCX140-B 10 mg Twice Daily	-14.5
CCX140-B 15 mg Twice Daily	5.1
Open-label Extension	-12.0

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Lymphocytes

Intervention	cells x 10^3/microlitre (Mean)
Placebo	-0.98
CCX140-B 5 mg Once Daily	0.45
CCX140-B 10 mg Twice Daily	0.37
CCX140-B 15 mg Twice Daily	-0.09
Open-label Extension	-0.09

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Lymphocytes/Leukocytes

Intervention	cells x 10^3/L (Mean)
Placebo	-0.080
CCX140-B 5 mg Once Daily	0.122
CCX140-B 10 mg Twice Daily	0.099
CCX140-B 15 mg Twice Daily	0.194
Open-label Extension	0.161

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Monocytes/Leukocytes

Intervention	percentage of lymphocytes in leukocytes (Mean)
Placebo	2.51
CCX140-B 5 mg Once Daily	0.06
CCX140-B 10 mg Twice Daily	-0.99
CCX140-B 15 mg Twice Daily	1.52
Open-label Extension	2.61

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Neutrophils

Intervention	percentage of monocytes in leukocytes (Mean)
Placebo	1.38
CCX140-B 5 mg Once Daily	0.25
CCX140-B 10 mg Twice Daily	0.99
CCX140-B 15 mg Twice Daily	0.56
Open-label Extension	-0.21

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Neutrophils/Leukocytes

Intervention	cells x 10^3/L (Mean)
Placebo	-0.954
CCX140-B 5 mg Once Daily	0.255
CCX140-B 10 mg Twice Daily	0.137
CCX140-B 15 mg Twice Daily	-0.289
Open-label Extension	-0.281

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Alanine Aminotransferase

Intervention	percentage of neutrophils in leukocytes (Mean)
Placebo	-4.28
CCX140-B 5 mg Once Daily	-0.39
CCX140-B 10 mg Twice Daily	-0.16
CCX140-B 15 mg Twice Daily	-2.28
Open-label Extension	-2.84

Normal Range: 6 - 41 U/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Alkaline Phosphatase

Intervention	U/L (Mean)
Placebo	0.5
CCX140-B 5 mg Once Daily	0.8
CCX140-B 10 mg Twice Daily	0.3
CCX140-B 15 mg Twice Daily	-1.8
Open-label Extension	0.0

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Amylase

Intervention	U/L (Mean)
Placebo	10.2
CCX140-B 5 mg Once Daily	-1.0
CCX140-B 10 mg Twice Daily	0.7
CCX140-B 15 mg Twice Daily	-1.9
Open-label Extension	2.3

Normal range: 22-123 U/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Aspartate Aminotransferase

Intervention	U/L (Mean)
Placebo	3.1
CCX140-B 5 mg Once Daily	8.9
CCX140-B 10 mg Twice Daily	5.0
CCX140-B 15 mg Twice Daily	3.9
Open-label Extension	5.2

Normal range : 9-34 U/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Bicarbonate

Intervention	U/L (Mean)
Placebo	18.3
CCX140-B 5 mg Once Daily	-0.4
CCX140-B 10 mg Twice Daily	-3.5
CCX140-B 15 mg Twice Daily	-3.2
Open-label Extension	-1.7

Normal range: 21-33 mmol/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Bilirubin

Intervention	mmol/L (Mean)
Placebo	0.5
CCX140-B 5 mg Once Daily	-0.4
CCX140-B 10 mg Twice Daily	0.9
CCX140-B 15 mg Twice Daily	-0.6
Open-label Extension	0.1

Normal range: 0.1-1.10 mg/dL (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma C Reactive Protein

Intervention	mg/dL (Mean)
Placebo	0.044
CCX140-B 5 mg Once Daily	-0.006
CCX140-B 10 mg Twice Daily	0.160
CCX140-B 15 mg Twice Daily	-0.012
Open-label Extension	0.050

Normal range: 0.0-3.0 mg/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Calcium

Intervention	mg/L (Mean)
Placebo	1.200
CCX140-B 5 mg Once Daily	2.144
CCX140-B 10 mg Twice Daily	-1.000
CCX140-B 15 mg Twice Daily	-1.444
Open-label Extension	0.260

Normal range: 8.5-10.5 mg/dL (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Chloride

Intervention	mg/dL (Mean)
Placebo	0.18
CCX140-B 5 mg Once Daily	0.20
CCX140-B 10 mg Twice Daily	0.17
CCX140-B 15 mg Twice Daily	-0.01
Open-label Extension	0.14

Normal range: 95-110 mmol/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Cholesterol

Normal range: 100-200 mg/dL (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Creatine Kinase

Normal range: 23-210 U/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Creatinine

Normal range: 0.62-1.44 mg/dL (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Cystatin C

Normal range: 0.53-0.95 mg/L (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Direct Bilirubin

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Glucose

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma HDL Cholesterol

HDL -High-density lipoprotein (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Indirect Bilirubin

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma LDL Cholesterol

LDL - Low-density lipoprotein (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Magnesium

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Pancreatic Lipase

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Phosphate

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Potassium

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Protein

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Sodium

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Triglycerides

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Urate

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Plasma Urea Nitrogen

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Platelets

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Prothrombin Intl. Normalised Ratio

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Prothrombin Time

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Reticulocytes/Erythrocytes

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in UPCR at Week 12

Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat (NCT03536754)
Timeframe: Baseline to Week 12

Change From Baseline in Urine Albumin

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Urine Creatinine

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Urine Protein

(NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Activated Partial Thromboplastin Time

Normal Range: 23.9 - 40.0 (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24

Change from baseline in eGFR calculated by the CKD-EPI Cystatin C equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation at Weeks 12 and 24. CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; MDRD: Modification of Diet in Renal Disease Open label extension covers Baseline to Week 12 and Baseline to Week 24 (NCT03536754)
Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)

TEAEs leading to study withdrawal means study drug discontinuation in this endpoint. (NCT03536754)
Timeframe: Baseline to Week 12, and Week 12 to Week 24

Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24

1. Proportion of subjects achieving complete renal remission by the following definition at Weeks 12 and 24 o Reduction in UPCR to <0.3 g/g o Serum albumin within normal range (for subjects with abnormal serum creatinine levels at baseline, return to normal levels for that age group; for subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels) 2. Proportion of subjects achieving partial remission defined as UPCR reduction of ≥50% from baseline and UPCR <3.5 g/g (definition 1), assessed at Weeks 12 and 24 3. Proportion of subjects achieving partial remission defined Decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in proteinuria from baseline (definition 2), assessed at Weeks 12 and 24 (NCT03536754)
Timeframe: Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension

Reviews

Trials

Other Studies

89 other studies available for prednisone and Glomerulosclerosis, Focal Segmental

Intervention	mg/dL (Mean)
Placebo	-2.7
CCX140-B 5 mg Once Daily	-2.0
CCX140-B 10 mg Twice Daily	18.9
CCX140-B 15 mg Twice Daily	-43.0
Open-label Extension	-5.6

Intervention	U/L (Mean)
Placebo	21.2
CCX140-B 5 mg Once Daily	18.1
CCX140-B 10 mg Twice Daily	-19.5
CCX140-B 15 mg Twice Daily	14.2
Open-label Extension	11.9

Intervention	mg/dL (Mean)
Placebo	0.060
CCX140-B 5 mg Once Daily	0.033
CCX140-B 10 mg Twice Daily	0.115
CCX140-B 15 mg Twice Daily	0.147
Open-label Extension	0.161

Intervention	mg/L (Mean)
Placebo	0.114
CCX140-B 5 mg Once Daily	0.104
CCX140-B 10 mg Twice Daily	0.093
CCX140-B 15 mg Twice Daily	0.018
Open-label Extension	0.087

Intervention	mg/dL (Mean)
Placebo	0.011
CCX140-B 5 mg Once Daily	0.008
CCX140-B 10 mg Twice Daily	0.005
CCX140-B 15 mg Twice Daily	-0.005
Open-label Extension	0.004

Intervention	mg/dL (Mean)
Placebo	-5.3
CCX140-B 5 mg Once Daily	1.1
CCX140-B 10 mg Twice Daily	1.5
CCX140-B 15 mg Twice Daily	-6.2
Open-label Extension	-0.9

Intervention	mg/dL (Mean)
Placebo	0.8
CCX140-B 5 mg Once Daily	-2.3
CCX140-B 10 mg Twice Daily	2.1
CCX140-B 15 mg Twice Daily	2.4
Open-label Extension	0.7

Intervention	mg/dL (Mean)
Placebo	0.043
CCX140-B 5 mg Once Daily	-0.009
CCX140-B 10 mg Twice Daily	0.054
CCX140-B 15 mg Twice Daily	-0.043
Open-label Extension	0.046

Intervention	mg/dL (Mean)
Placebo	12.2
CCX140-B 5 mg Once Daily	-2.8
CCX140-B 10 mg Twice Daily	8.0
CCX140-B 15 mg Twice Daily	-8.9
Open-label Extension	-5.0

Intervention	mg/dL (Mean)
Placebo	0.10
CCX140-B 5 mg Once Daily	0.02
CCX140-B 10 mg Twice Daily	-0.02
CCX140-B 15 mg Twice Daily	0.09
Open-label Extension	0.01

Intervention	mg/dL (Mean)
Placebo	16.6
CCX140-B 5 mg Once Daily	5.7
CCX140-B 10 mg Twice Daily	-16.5
CCX140-B 15 mg Twice Daily	-23.2
Open-label Extension	-2.6

Intervention	mg/dL (Mean)
Placebo	0.51
CCX140-B 5 mg Once Daily	0.04
CCX140-B 10 mg Twice Daily	-0.28
CCX140-B 15 mg Twice Daily	-0.08
Open-label Extension	-0.05

Intervention	cells x 10^9/L (Mean)
Placebo	5.2
CCX140-B 5 mg Once Daily	26.2
CCX140-B 10 mg Twice Daily	4.8
CCX140-B 15 mg Twice Daily	0.9
Open-label Extension	19.1

Intervention	second (Mean)
Placebo	0.48
CCX140-B 5 mg Once Daily	0.07
CCX140-B 10 mg Twice Daily	0.69
CCX140-B 15 mg Twice Daily	0.33
Open-label Extension	0.78

Intervention	g protein/g creatinine (Least Squares Mean)
Placebo	0.83
CCX140-B 5 mg Once Daily	1.02
CCX140-B 10 mg Twice Daily	1.12
CCX140-B 15 mg Twice Daily	0.87

Intervention	mg/dL (Mean)
Placebo	1.117
CCX140-B 5 mg Once Daily	-19.044
CCX140-B 10 mg Twice Daily	-8.455
CCX140-B 15 mg Twice Daily	-35.964
Open-label Extension	-28.433

Intervention	mg/dL (Mean)
Placebo	10.65
CCX140-B 5 mg Once Daily	-11.67
CCX140-B 10 mg Twice Daily	-15.37
CCX140-B 15 mg Twice Daily	25.30
Open-label Extension	-6.96

Intervention	mg/dL (Mean)
Placebo	-19.3
CCX140-B 5 mg Once Daily	-8.9
CCX140-B 10 mg Twice Daily	-9.0
CCX140-B 15 mg Twice Daily	-80.6
Open-label Extension	-35.1

Intervention	second (Mean)
	Week 12	Week 24
CCX140-B 10 mg Twice Daily	2.36	2.34
CCX140-B 15 mg Twice Daily	1.28	0.10
CCX140-B 5 mg Once Daily	2.05	1.39
Open-label Extension	1.76	1.76
Placebo	2.40	2.91

Intervention	mL/min/1.73 m^2 (Mean)
	CKD-EPI Cystatin C equation Week 12	CKD-EPI Cystatin C equation Week 24	CKD-EPI Creatinine equation Week 12	CKD-EPI Creatinine equation Week 24	CKD-EPI Creatinine-Cystatin C equation Week 12	CKD-EPI Creatinine-Cystatin C equation Week 24	MDRD Creatinine equation Week 12	MDRD Creatinine equation Week 24
CCX140-B 10 mg Twice Daily	-1.6	-1.3	-3.9	-5.3	-2.6	-3.2	-4.6	-5.9
CCX140-B 15 mg Twice Daily	0.2	-3.2	-4.8	-2.0	-2.8	-2.8	-6.7	-4.0
CCX140-B 5 mg Once Daily	-3.1	-3.2	-4.2	-8.2	-3.5	-5.5	-5.1	-8.8
Open-label Extension	-1.7	-2.0	-4.7	-4.7	-3.2	-3.4	-5.6	-5.8
Placebo	-4.9	-0.8	-3.0	-3.1	-5.3	-2.4	-4.7	-4.5

Intervention	Participants (Count of Participants)
	TEAEs	SAEs	TEAEs leading to study withdrawal
CCX140-B 10 mg Twice Daily	8	0	1
CCX140-B 15 mg Twice Daily	7	0	0
CCX140-B 5 mg Once Daily	6	0	0
Open-label Extension	24	1	2
Placebo	10	0	0

Intervention	Participants (Count of Participants)
	Complete renal remission	Partial remission (definition 1)	Partial remission (definition 2)
CCX140-B 10 mg Twice Daily	0	0	0
CCX140-B 15 mg Twice Daily	0	1	0
CCX140-B 5 mg Once Daily	0	0	0
Open-label Extension	0	4	6
Placebo	0	1	0

Article	Year
Raised serum creatinine at presentation does not adversely affect steroid response in primary focal segmental glomerulosclerosis in adults. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2012, Volume: 27, Issue:3 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Creatinine; Female; Fluorescent Antibody Technique; Foll	2012
Novel therapy of focal glomerulosclerosis with mycophenolate and angiotensin blockade. Pediatric nephrology (Berlin, Germany), 2003, Volume: 18, Issue:8 Topics: Adolescent; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Anti-Inflamm	2003
A combined low-density lipoprotein apheresis and prednisone therapy for steroid-resistant primary focal segmental glomerulosclerosis in children. American journal of kidney diseases : the official journal of the National Kidney Foundation, 2003, Volume: 42, Issue:6 Topics: Adolescent; Blood Component Removal; Cellulose; Child; Combined Modality Therapy; Cyclosporine; Dext	2003
Cyclophosphamide in the treatment of focal segmental glomerulosclerosis. Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas, 2004, Volume: 37, Issue:9 Topics: Adolescent; Adult; Child; Cyclophosphamide; Drug Resistance; Drug Therapy, Combination; Female; Foll	2004
Prednisone/cyclophosphamide treatment in adult-onset autosomal dominant familial focal segmental glomerulosclerosis (FSGS 1). Clinical nephrology, 2006, Volume: 65, Issue:6 Topics: Administration, Oral; Adult; Age of Onset; Chromosome Disorders; Creatinine; Cyclophosphamide; Dose-	2006
Steroid therapy and prognosis of focal segmental glomerulosclerosis in the elderly. Clinical nephrology, 1994, Volume: 42, Issue:1 Topics: Aged; Cyclophosphamide; Drug Therapy, Combination; Female; Follow-Up Studies; Glomerulosclerosis, Fo	1994
Long-term cyclosporine therapy for pediatric nephrotic syndrome: a clinical and histologic analysis. Journal of the American Society of Nephrology : JASN, 1996, Volume: 7, Issue:4 Topics: Adolescent; Biopsy; Child; Child, Preschool; Cyclosporine; Drug Therapy, Combination; Female; Glomer	1996
Treatment of childhood nephrotic syndrome. Journal of the American Society of Nephrology : JASN, 1992, Volume: 3, Issue:4 Topics: Administration, Oral; Alkylating Agents; Angiotensin-Converting Enzyme Inhibitors; Child; Clinical P	1992
Treatment of adult idiopathic nephrotic syndrome with cyclosporin A: minimal-change disease and focal-segmental glomerulosclerosis. Collaborative Group of the French Society of Nephrology. Clinical nephrology, 1991, Volume: 35 Suppl 1 Topics: Adult; Cyclosporins; Drug Evaluation; Drug Therapy, Combination; Drug Tolerance; Glomerulosclerosis,	1991
A randomized controlled trial of low-dose prednisone and ciclosporin versus high-dose prednisone in nephrotic syndrome of children. Nephron, 1991, Volume: 59, Issue:1 Topics: Adolescent; Child; Child, Preschool; Cyclosporine; Glomerulonephritis, Membranous; Glomerulosclerosi	1991
[Programs of immunosuppressive and anti-inflammatory treatment of primary idiopathic glomerulonephritis. I. Submicroscopic and focal segmental glomerulonephritis]. Przeglad lekarski, 1989, Volume: 46, Issue:10 Topics: Adult; Child; Clinical Trials as Topic; Cyclophosphamide; Cyclosporins; Dose-Response Relationship,	1989
[New results concerning the effectiveness of therapy of chronic glomerulonephritis. Results of cytostatics-anticoagulants-aggregation inhibitors, cystostatics-anticoagulants-aggregation inhibitors-prednisone and cystostatics-prednisone therapy, derived fr Zeitschrift fur Urologie und Nephrologie, 1986, Volume: 79, Issue:8 Topics: Anticoagulants; Chlorambucil; Chronic Disease; Clinical Trials as Topic; Drug Evaluation; Drug Thera	1986
[Drug treatment of chronic glomerulonephritis: pro]. Klinische Wochenschrift, 1985, Sep-16, Volume: 63, Issue:18 Topics: Chlorambucil; Chronic Disease; Clinical Trials as Topic; Cyclophosphamide; Cyclosporins; Glomerulone	1985