carbamates has been researched along with Kidney Failure, Chronic in 43 studies
Kidney Failure, Chronic: The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Systematic search of Pubmed, Embase, Scopus, and Google Scholar was conducted using the search term (end-stage renal disease OR renal replacement therapy OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR haemodialysis OR dialysis OR peritoneal dialysis) AND (sofosbuvir OR velpatasvir OR NS5A inhibitors OR directly acting antivirals)." | 9.22 | Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta-analysis. ( De, A; Duseja, A; Mishra, S; Premkumar, M; Roy, A; Singh, V; Taneja, S; Verma, N, 2022) |
| "There is emerging data on the use of Sofosbuvir-based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance haemodialysis (MHD)." | 8.02 | Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis. ( De, A; Dhiman, RK; Duseja, A; Kohli, HS; Kumar, V; Mehta, M; Premkumar, M; Ramachandran, R; Ratho, RK; Singh, MP; Singh, V; Taneja, S; Verma, N, 2021) |
| "There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1." | 7.88 | Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease. ( Chawla, Y; De, A; Dhiman, RK; Duseja, A; Gupta, KL; Kohli, HS; Kumar, V; Mehta, M; Ramachandran, R; Taneja, S, 2018) |
| " It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN." | 5.56 | Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience. ( Abd-Elsalam, S; Abo-Amer, YE; Ahmed, R; Badawi, R; El-Abgeegy, M; Elguindy, AMA; Elkadeem, M; Elsergany, HF; Elshweikh, SA; Hawash, N; Mansour, L; Mohmed, AA; Soliman, MY; Soliman, S, 2020) |
| "5%) patients (calcium channel blockers, ACE inhibitors, statins, diuretics, tacrolimus); four patients required further adjustment of antihypertensive drugs or tacrolimus dosage on-treatment." | 5.48 | Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort. ( Chmelova, K; Frankova, S; Kreidlova, M; Merta, D; Senkerikova, R; Sperl, J, 2018) |
| "Systematic search of Pubmed, Embase, Scopus, and Google Scholar was conducted using the search term (end-stage renal disease OR renal replacement therapy OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR haemodialysis OR dialysis OR peritoneal dialysis) AND (sofosbuvir OR velpatasvir OR NS5A inhibitors OR directly acting antivirals)." | 5.22 | Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta-analysis. ( De, A; Duseja, A; Mishra, S; Premkumar, M; Roy, A; Singh, V; Taneja, S; Verma, N, 2022) |
| "There is emerging data on the use of Sofosbuvir-based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance haemodialysis (MHD)." | 4.02 | Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis. ( De, A; Dhiman, RK; Duseja, A; Kohli, HS; Kumar, V; Mehta, M; Premkumar, M; Ramachandran, R; Ratho, RK; Singh, MP; Singh, V; Taneja, S; Verma, N, 2021) |
| "There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1." | 3.88 | Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease. ( Chawla, Y; De, A; Dhiman, RK; Duseja, A; Gupta, KL; Kohli, HS; Kumar, V; Mehta, M; Ramachandran, R; Taneja, S, 2018) |
| "To assess the cost-effectiveness of the elbasvir/grazoprevir (EBR/GZR) regimen in patients with genotype 1 chronic hepatitis C virus (HCV) infection with severe and end-stage renal disease compared to no treatment." | 3.88 | Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France. ( Abergel, A; Clément, A; Di Martino, V; Durand-Zaleski, I; Levy-Bachelot, L; Maunoury, F; Nwankwo, C; Thervet, E, 2018) |
| "To describe the phase 1 and population pharmacokinetic investigations that support dosing recommendations for elbasvir/grazoprevir (EBR/GZR) in hepatitis C virus-infected people with advanced chronic kidney disease." | 2.90 | Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment. ( Bhagunde, P; Butterton, JR; Caro, L; Du, L; Fandozzi, C; Feng, HP; Guo, Z; Iwamoto, M; Marshall, WL; Panebianco, D; Wenning, L; Yeh, WW, 2019) |
| " Adverse events included headache (n = 1) and nausea (n = 1)." | 2.90 | Single-Dose Pharmacokinetics and Safety of Solriamfetol in Participants With Normal or Impaired Renal Function and With End-Stage Renal Disease Requiring Hemodialysis. ( Chen, D; Lasseter, K; Lee, L; Marbury, T; Zomorodi, K, 2019) |
| "Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population." | 2.90 | Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. ( Agarwal, K; Ampuero, J; Ben-Ari, Z; Borgia, SM; Brown, A; Bruck, R; Calleja, JL; Cooper, C; Cramp, ME; Dearden, J; Dvory-Sobol, H; Esteban, R; Fox, R; Foxton, M; Gane, EJ; Haider, S; Hyland, R; Kirby, BJ; Lu, S; Lurie, Y; Markova, S; Meng, A; Osinusi, AO; Rodriguez, CF; Ryder, SD; Shafran, SD; Shaw, D; Willems, B; Yoshida, EM, 2019) |
| " No adverse constitutional events were observed in either of the groups." | 2.82 | Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis. ( Iio, E; Ishikawa, T; Kumada, T; Tada, T; Takaguchi, K; Tanaka, Y; Toyoda, H; Tsuji, K; Zeniya, M, 2016) |
| "Observed DCV exposure increases were within the normal range of variability and were not associated with an elevated risk of adverse events." | 2.80 | Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment. ( Alcorn, H; Bertz, R; Bifano, M; Garimella, T; Hwang, C; Kandoussi, H; Luo, WL; Marbury, TC; Sherman, D; Wang, R, 2015) |
| "The objective of this study was to describe a population pharmacokinetic analysis of gabapentin enacarbil in patients with varying degrees of renal function, using data from an open-label study of gabapentin enacarbil in patients with renal impairment (XenoPort, Inc." | 2.77 | Clinical pharmacokinetics of gabapentin after administration of gabapentin enacarbil extended-release tablets in patients with varying degrees of renal function using data from an open-label, single-dose pharmacokinetic study. ( Blumenthal, R; Chen, D; Cundy, KC; Ho, J; Lal, R; Luo, W; Sukbuntherng, J, 2012) |
| "Most HCV(+) patients with ESRD are genotype 1: in that setting, a recent study reported that the association of grazoprevir/elbasvir 100/50 mg/day led to a SVR of nearly 95% with very few side effects." | 2.53 | Use of direct-acting agents for hepatitis C virus-positive kidney transplant candidates and kidney transplant recipients. ( Alric, L; Kamar, N; Rostaing, L, 2016) |
| " This study was to evaluate the pharmacokinetic characteristics and effectiveness of daclatasvir/sofosbuvir (DAC/SOF) and ledipasvir/SOF (LDV/SOF) in HD patients." | 1.56 | Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease. ( Feng, Z; Gao, H; Huang, R; Li, Z; Liang, X; Lin, T; Liu, S; Ma, J; Wang, X; Xu, L; Zhang, L, 2020) |
| " It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN." | 1.56 | Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience. ( Abd-Elsalam, S; Abo-Amer, YE; Ahmed, R; Badawi, R; El-Abgeegy, M; Elguindy, AMA; Elkadeem, M; Elsergany, HF; Elshweikh, SA; Hawash, N; Mansour, L; Mohmed, AA; Soliman, MY; Soliman, S, 2020) |
| "5%) patients (calcium channel blockers, ACE inhibitors, statins, diuretics, tacrolimus); four patients required further adjustment of antihypertensive drugs or tacrolimus dosage on-treatment." | 1.48 | Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort. ( Chmelova, K; Frankova, S; Kreidlova, M; Merta, D; Senkerikova, R; Sperl, J, 2018) |
| "New highly effective treatments for chronic hepatitis C virus (HCV) infection are now available, but safety and efficacy data on the use of anti-HCV therapies in patients with renal failure, particularly those requiring PD, remain limited." | 1.46 | Successful treatment of chronic hepatitis C virus infection in a patient receiving daily peritoneal dialysis. ( Cole, J; Stark, JE, 2017) |
| "Homocitrulline was present in glomerular basement membrane (8/10), mesangium (8/10), tubular epithelium and cytoplasm (7/10) and Bowman's capsule (1/10) in patients with elevated BUN." | 1.31 | Carbamoylation of glomerular and tubular proteins in patients with kidney failure: a potential mechanism of ongoing renal damage. ( Gaber, L; Handorf, CR; Kraus, AP; Kraus, LM; Marti, HP, 2001) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 4 (9.30) | 18.7374 |
| 1990's | 1 (2.33) | 18.2507 |
| 2000's | 3 (6.98) | 29.6817 |
| 2010's | 30 (69.77) | 24.3611 |
| 2020's | 5 (11.63) | 2.80 |
| Authors | Studies |
|---|---|
| Farouk, F | 1 |
| Wahba, D | 1 |
| Mogawer, S | 1 |
| Elkholy, S | 1 |
| Elmeligui, A | 1 |
| Abdelghani, R | 1 |
| Ibahim, S | 1 |
| Cheema, SUR | 1 |
| Rehman, MS | 1 |
| Hussain, G | 1 |
| Cheema, SS | 1 |
| Gilani, N | 1 |
| Tatar, B | 1 |
| Köse, Ş | 1 |
| Ergun, NC | 1 |
| Turken, M | 1 |
| Onlen, Y | 1 |
| Yılmaz, Y | 1 |
| Akhan, S | 1 |
| Lin, T | 1 |
| Wang, X | 1 |
| Gao, H | 2 |
| Feng, Z | 1 |
| Xu, L | 1 |
| Ma, J | 1 |
| Li, Z | 1 |
| Zhang, L | 1 |
| Huang, R | 1 |
| Liang, X | 1 |
| Liu, S | 1 |
| Taneja, S | 3 |
| Duseja, A | 3 |
| Mehta, M | 2 |
| De, A | 3 |
| Verma, N | 2 |
| Premkumar, M | 2 |
| Dhiman, RK | 2 |
| Singh, V | 2 |
| Singh, MP | 1 |
| Ratho, RK | 1 |
| Ramachandran, R | 2 |
| Kumar, V | 2 |
| Kohli, HS | 2 |
| Abd-Elsalam, S | 1 |
| Abo-Amer, YE | 1 |
| El-Abgeegy, M | 1 |
| Elshweikh, SA | 1 |
| Elsergany, HF | 1 |
| Ahmed, R | 1 |
| Elkadeem, M | 1 |
| Hawash, N | 1 |
| Soliman, S | 1 |
| Badawi, R | 1 |
| Elguindy, AMA | 1 |
| Soliman, MY | 1 |
| Mohmed, AA | 1 |
| Mansour, L | 1 |
| Roy, A | 1 |
| Mishra, S | 1 |
| Bhamidimarri, KR | 1 |
| Ladino, M | 1 |
| Pedraza, F | 1 |
| Guerra, G | 1 |
| Mattiazzi, A | 1 |
| Chen, L | 1 |
| Ciancio, G | 1 |
| Kupin, W | 1 |
| Martin, P | 1 |
| Burke, G | 1 |
| Roth, D | 1 |
| Stark, JE | 1 |
| Cole, J | 1 |
| He, YL | 1 |
| Yang, SJ | 1 |
| Hu, CH | 1 |
| Dong, J | 1 |
| Yan, TT | 1 |
| Liu, JF | 1 |
| Yang, Y | 1 |
| Ren, DF | 1 |
| Zhu, L | 1 |
| Zhao, YR | 1 |
| Chen, TY | 1 |
| Gupta, KL | 1 |
| Chawla, Y | 1 |
| Maunoury, F | 1 |
| Clément, A | 1 |
| Nwankwo, C | 1 |
| Levy-Bachelot, L | 1 |
| Abergel, A | 1 |
| Di Martino, V | 1 |
| Thervet, E | 1 |
| Durand-Zaleski, I | 1 |
| García-Agudo, R | 1 |
| Aoufi-Rabih, S | 1 |
| Salgueira-Lazo, M | 1 |
| González-Corvillo, C | 1 |
| Fabrizi, F | 1 |
| Sperl, J | 1 |
| Kreidlova, M | 1 |
| Merta, D | 1 |
| Chmelova, K | 1 |
| Senkerikova, R | 1 |
| Frankova, S | 1 |
| Orita, N | 1 |
| Shimakami, T | 1 |
| Sunagozaka, H | 1 |
| Horii, R | 1 |
| Nio, K | 1 |
| Terashima, T | 1 |
| Iida, N | 1 |
| Kitahara, M | 1 |
| Takatori, H | 1 |
| Kawaguchi, K | 1 |
| Kitamura, K | 1 |
| Arai, K | 1 |
| Yamashita, T | 2 |
| Sakai, Y | 1 |
| Mizukoshi, E | 1 |
| Honda, M | 1 |
| Kaneko, S | 1 |
| Mekky, MA | 1 |
| Abdel-Malek, MO | 1 |
| Osman, HA | 1 |
| Abdel-Aziz, EM | 1 |
| Hashim, AA | 1 |
| Hetta, HF | 1 |
| Morsy, KH | 1 |
| Yaraş, S | 1 |
| Üçbilek, E | 1 |
| Özdoğan, O | 1 |
| Ateş, F | 1 |
| Altıntaş, E | 1 |
| Sezgin, O | 1 |
| Caro, L | 1 |
| Wenning, L | 1 |
| Feng, HP | 1 |
| Guo, Z | 1 |
| Du, L | 1 |
| Bhagunde, P | 1 |
| Fandozzi, C | 1 |
| Panebianco, D | 1 |
| Marshall, WL | 1 |
| Butterton, JR | 1 |
| Iwamoto, M | 1 |
| Yeh, WW | 1 |
| Duerr, M | 1 |
| Schrezenmeier, EV | 1 |
| Lehner, LJ | 1 |
| Bergfeld, L | 1 |
| Glander, P | 1 |
| Marticorena Garcia, SR | 1 |
| Althoff, CE | 1 |
| Sack, I | 1 |
| Brakemeier, S | 1 |
| Eckardt, KU | 1 |
| Budde, K | 1 |
| Halleck, F | 1 |
| Özer Etik, D | 1 |
| Suna, N | 1 |
| Öcal, S | 1 |
| Selçuk, H | 1 |
| Dağlı, Ü | 1 |
| Çolak, T | 1 |
| Hilmioğlu, F | 1 |
| Boyacıoğlu, AS | 1 |
| Haberal, M | 1 |
| Zomorodi, K | 1 |
| Chen, D | 2 |
| Lee, L | 1 |
| Lasseter, K | 1 |
| Marbury, T | 1 |
| Borgia, SM | 1 |
| Dearden, J | 1 |
| Yoshida, EM | 1 |
| Shafran, SD | 1 |
| Brown, A | 1 |
| Ben-Ari, Z | 1 |
| Cramp, ME | 1 |
| Cooper, C | 1 |
| Foxton, M | 1 |
| Rodriguez, CF | 1 |
| Esteban, R | 1 |
| Hyland, R | 1 |
| Lu, S | 1 |
| Kirby, BJ | 1 |
| Meng, A | 1 |
| Markova, S | 1 |
| Dvory-Sobol, H | 1 |
| Osinusi, AO | 1 |
| Bruck, R | 1 |
| Ampuero, J | 1 |
| Ryder, SD | 1 |
| Agarwal, K | 1 |
| Fox, R | 1 |
| Shaw, D | 1 |
| Haider, S | 1 |
| Willems, B | 1 |
| Lurie, Y | 1 |
| Calleja, JL | 1 |
| Gane, EJ | 1 |
| Gillery, P | 1 |
| Jaisson, S | 1 |
| Kalim, S | 3 |
| Tamez, H | 1 |
| Wenger, J | 1 |
| Ankers, E | 1 |
| Trottier, CA | 2 |
| Deferio, JJ | 2 |
| Berg, AH | 3 |
| Karumanchi, SA | 3 |
| Thadhani, RI | 3 |
| Tompson, DJ | 1 |
| Buraglio, M | 1 |
| Bullman, J | 1 |
| Crean, CS | 1 |
| Rayner, K | 1 |
| Garimella, T | 1 |
| Wang, R | 1 |
| Luo, WL | 1 |
| Hwang, C | 1 |
| Sherman, D | 1 |
| Kandoussi, H | 1 |
| Marbury, TC | 1 |
| Alcorn, H | 1 |
| Bertz, R | 1 |
| Bifano, M | 1 |
| Ortiz, G | 1 |
| Toyoda, H | 1 |
| Kumada, T | 1 |
| Tada, T | 1 |
| Takaguchi, K | 1 |
| Ishikawa, T | 1 |
| Tsuji, K | 1 |
| Zeniya, M | 1 |
| Iio, E | 1 |
| Tanaka, Y | 1 |
| Pockros, PJ | 1 |
| Reddy, KR | 1 |
| Mantry, PS | 1 |
| Cohen, E | 1 |
| Bennett, M | 1 |
| Sulkowski, MS | 1 |
| Bernstein, DE | 1 |
| Cohen, DE | 1 |
| Shulman, NS | 1 |
| Wang, D | 1 |
| Khatri, A | 1 |
| Abunimeh, M | 1 |
| Podsadecki, T | 1 |
| Lawitz, E | 1 |
| Ackens, R | 1 |
| Posthouwer, D | 1 |
| Gevers, TJ | 1 |
| Burger, D | 1 |
| Schipper-Reintjes, E | 1 |
| Kooistra, MP | 1 |
| Richter, C | 1 |
| Rostaing, L | 1 |
| Alric, L | 1 |
| Kamar, N | 1 |
| Ponziani, FR | 1 |
| Siciliano, M | 1 |
| Lionetti, R | 1 |
| Pasquazzi, C | 1 |
| Gianserra, L | 1 |
| D'Offizi, G | 1 |
| Gasbarrini, A | 1 |
| Pompili, M | 1 |
| Lal, R | 1 |
| Sukbuntherng, J | 1 |
| Luo, W | 1 |
| Blumenthal, R | 1 |
| Ho, J | 1 |
| Cundy, KC | 1 |
| Oimomi, M | 2 |
| Ishikawa, K | 2 |
| Kawasaki, T | 2 |
| Kubota, S | 2 |
| Yoshimura, Y | 1 |
| Baba, S | 2 |
| Davenport, A | 1 |
| Jones, S | 1 |
| Goel, S | 1 |
| Astley, JP | 1 |
| Feest, TG | 1 |
| Kraus, LM | 2 |
| Kraus, AP | 2 |
| Gaber, L | 1 |
| Handorf, CR | 1 |
| Marti, HP | 1 |
| Hasuike, Y | 1 |
| Nakanishi, T | 1 |
| Maeda, K | 1 |
| Tanaka, T | 1 |
| Inoue, T | 1 |
| Takamitsu, Y | 1 |
| Hatanaka, H | 1 |
| Takagi, K | 1 |
| Tanke, G | 1 |
| Erill, S | 1 |
| du Souich, P | 1 |
| Courteau, H | 1 |
| Fishback, DB | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Evaluation of the Clinical Effects of Ombitasvir/Paritaprevir/Ritonavir Regimen in the Treatment of Chronic HCV Patients in CKD Versus ESRD Patients in Assiut University Hospital[NCT03341988] | Phase 1 | 100 participants (Actual) | Interventional | 2017-11-22 | Completed | ||
| An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency[NCT01937975] | Phase 1 | 24 participants (Actual) | Interventional | 2013-09-06 | Completed | ||
| A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease[NCT02092350] | Phase 2/Phase 3 | 237 participants (Actual) | Interventional | 2014-03-17 | Completed | ||
| A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease[NCT03036852] | Phase 2 | 59 participants (Actual) | Interventional | 2017-03-22 | Completed | ||
| Amino Acid Therapy to Modify Protein Carbamylation in End Stage Renal Disease: A Randomized Trial[NCT02472834] | 54 participants (Actual) | Interventional | 2016-02-29 | Completed | |||
| Single Dose Pharmacokinetics and Safety of Daclatasvir in Subjects With Renal Function Impairment[NCT01830205] | Phase 1 | 58 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| Amino Acid Therapy to Modify Protein Carbamylation in End Stage Renal Disease[NCT01612429] | Early Phase 1 | 23 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal[NCT02207088] | Phase 3 | 68 participants (Actual) | Interventional | 2014-09-23 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 23.04 |
| Participants With Severe Renal Impairment: Day 10 | 28.97 |
| Healthy Participants: Day 10 | 25.02 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 28.38 |
| Participants With Severe Renal Impairment: Day 10 | 36.30 |
| Healthy Participants: Day 10 | 35.18 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 857 |
| Participants With Severe Renal Impairment: Day 10 | 569 |
| Healthy Participants: Day 10 | 901 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 5430 |
| Participants With Severe Renal Impairment: Day 10 | 3490 |
| Healthy Participants: Day 10 | 5760 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters/hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 25.9 |
| Participants With End Stage Renal Disease | 29.9 | 26.2 |
| Participants With Severe Renal Impairment: Day 10 | NA | 13.9 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters/hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 114 |
| Participants With End Stage Renal Disease | 135 | 138 |
| Participants With Severe Renal Impairment: Day 10 | NA | 69.4 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | uM*hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 2.19 |
| Participants With End Stage Renal Disease | 1.89 | 2.16 |
| Participants With Severe Renal Impairment: Day 10 | NA | 4.07 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | uM*hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 1.14 |
| Participants With End Stage Renal Disease | 0.969 | 0.944 |
| Participants With Severe Renal Impairment: Day 10 | NA | 1.88 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | uM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 0.163 |
| Participants With End Stage Renal Disease | 0.137 | 0.154 |
| Participants With Severe Renal Impairment: Day 10 | NA | 0.271 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | uM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 0.154 |
| Participants With End Stage Renal Disease | 0.141 | 0.135 |
| Participants With Severe Renal Impairment: Day 10 | NA | 0.255 |
Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: 24 hours postdose
| Intervention | nM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 60.9 |
| Participants With End Stage Renal Disease | 46.9 | 58.2 |
| Participants With Severe Renal Impairment: Day 10 | NA | 126 |
Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: 24 hours postdose
| Intervention | nM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 14.5 |
| Participants With End Stage Renal Disease | 11.4 | 11.3 |
| Participants With Severe Renal Impairment: Day 10 | NA | 23.3 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Median) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 4.00 |
| Participants With End Stage Renal Disease | 4.00 | 5.00 |
| Participants With Severe Renal Impairment: Day 10 | NA | 4.00 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Median) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 2.50 |
| Participants With End Stage Renal Disease | 2.00 | 2.50 |
| Participants With Severe Renal Impairment: Day 10 | NA | 3.00 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group. (NCT02092350)
Timeframe: Up to Week 12
| Intervention | Participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 0 |
| Deferred Treatment | 5 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group. (NCT02092350)
Timeframe: Up to Week 14
| Intervention | Participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 93 |
| Deferred Treatment | 96 |
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL. (NCT02092350)
Timeframe: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 99.1 |
| Deferred Treatment | 98.0 |
SVR24 was defined as HCV RNA
Timeframe: Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 97.4 |
| Deferred Treatment Group | 98.0 |
SVR4 was defined as HCV RNA
Timeframe: Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 100.00 |
| Deferred Treatment Group | 99.0 |
Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL. (NCT03036852)
Timeframe: First dose date up to Posttreatment Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| SOF/VEL | 0 |
(NCT03036852)
Timeframe: First dose date up to Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment. (NCT03036852)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 94.9 |
| SOF/VEL (GT-1) | 92.0 |
| SOF/VEL (GT-2) | 100.0 |
| SOF/VEL (GT-3) | 93.8 |
| SOF/VEL (GT-4) | 100.0 |
| SOF/VEL (GT-6) | 100.0 |
| SOF/VEL (Indeterminate) | 100.0 |
SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 94.9 |
| SOF/VEL (GT-1) | 92.0 |
| SOF/VEL (GT-2) | 100.0 |
| SOF/VEL (GT-3) | 93.8 |
| SOF/VEL (GT-4) | 100.0 |
| SOF/VEL (GT-6) | 100.0 |
| SOF/VEL (Indeterminate) | 100.0 |
SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 96.6 |
| SOF/VEL (GT-1) | 96.0 |
| SOF/VEL (GT-2) | 100.0 |
| SOF/VEL (GT-3) | 93.8 |
| SOF/VEL (GT-4) | 100.0 |
| SOF/VEL (GT-6) | 100.0 |
| SOF/VEL (Indeterminate) | 100.0 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT03036852)
Timeframe: Baseline to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 3.4 |
| SOF/VEL (GT-1) | 4.0 |
| SOF/VEL (GT-2) | 0 |
| SOF/VEL (GT-3) | 6.3 |
| SOF/VEL (GT-4) | 0 |
| SOF/VEL (GT-6) | 0 |
| SOF/VEL (Indeterminate) | 0 |
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | h*ng/mL (Mean) |
|---|---|
| SOF/VEL | 2381.9 |
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | h*ng/mL (Mean) |
|---|---|
| SOF/VEL | 230989.2 |
AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | h*ng/mL (Mean) |
|---|---|
| SOF/VEL | 4279.4 |
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 9776.2 |
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 1041.0 |
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 226.9 |
Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 137.2 |
(NCT03036852)
Timeframe: Baseline; Weeks 2, 4, 6, 8, and 12
| Intervention | log10 IU/mL (Mean) | ||||
|---|---|---|---|---|---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 12 | |
| SOF/VEL (GT-1) | -4.69 | -4.81 | -4.81 | -4.81 | -4.81 |
| SOF/VEL (GT-2) | -3.78 | -4.05 | -4.05 | -4.05 | -4.05 |
| SOF/VEL (GT-3) | -5.07 | -5.20 | -5.20 | -5.20 | -5.20 |
| SOF/VEL (GT-4) | -4.23 | -4.48 | -4.48 | -4.48 | -4.48 |
| SOF/VEL (GT-6) | -5.29 | -5.29 | -5.29 | -5.29 | -5.29 |
| SOF/VEL (Indeterminate) | -3.24 | -3.26 | -3.26 | -3.26 | -3.26 |
| SOF/VEL (Total) | -4.54 | -4.69 | -4.69 | -4.69 | -4.69 |
(NCT03036852)
Timeframe: Weeks 2, 4, 6, 8, and 12
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | |
| SOF/VEL (GT-1) | 76.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-2) | 85.7 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-3) | 43.8 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-4) | 50.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-6) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (Indeterminate) | 80.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (Total) | 67.8 | 100.0 | 100.0 | 100.0 | 100.0 |
Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | milliliter/minute (mL/min) (Geometric Mean) |
|---|---|
| Normal Renal Function | 89.164 |
| Mild Renal Impairment | 47.034 |
| Moderate Renal Impairment | 40.339 |
| Severe Renal Impairment | 45.565 |
| End Stage Renal Disease | 70.139 |
The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | Liters (Geometric Mean) |
|---|---|
| Normal Renal Function | 105.157 |
| Mild Renal Impairment | 63.761 |
| Moderate Renal Impairment | 59.054 |
| Severe Renal Impairment | 79.769 |
| End Stage Renal Disease | 95.186 |
AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | nanograms*hours/milliliter (ng*h/mL) (Geometric Mean) |
|---|---|
| Normal Renal Function | 11215.264 |
| Mild Renal Impairment | 21261.199 |
| Moderate Renal Impairment | 24789.951 |
| Severe Renal Impairment | 21946.450 |
| End Stage Renal Disease | 14257.489 |
AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng*hour (h)/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 11092.967 |
| Mild Renal Impairment | 20852.129 |
| Moderate Renal Impairment | 24343.711 |
| Severe Renal Impairment | 21238.909 |
| End Stage Renal Disease | 13934.562 |
Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 1111.497 |
| Mild Renal Impairment | 1619.572 |
| Moderate Renal Impairment | 1745.845 |
| Severe Renal Impairment | 1207.137 |
| End Stage Renal Disease | 1085.344 |
The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined. (NCT01830205)
Timeframe: Baseline up to Day 5 post dose
| Intervention | Participants (Number) |
|---|---|
| Normal Renal Function/Mild Renal Impairment | 0 |
| Mild/Moderate Renal Impairment | 0 |
| Mild/Severe Renal Impairment | 0 |
| End Stage Renal Disease | 0 |
Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. (NCT01830205)
Timeframe: Baseline up to Day 5 post dose
| Intervention | Participants (Number) |
|---|---|
| Normal Renal Function/Mild Renal Impairment | 0 |
| Mild/Moderate Renal Impairment | 0 |
| Mild/Severe Renal Impairment | 0 |
| End Stage Renal Disease | 0 |
The total number of participants with abnormal range vital signs which were considered as adverse events was determined. (NCT01830205)
Timeframe: Baseline up to Day 5 post dose
| Intervention | Participants (Number) |
|---|---|
| Normal Renal Function/Mild Renal Impairment | 0 |
| Mild/Moderate Renal Impairment | 0 |
| Mild/Severe Renal Impairment | 0 |
| End Stage Renal Disease | 1 |
The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | Percentage of daclatasvir recovered (Geometric Mean) |
|---|---|
| Normal Renal Function | 5.007 |
| Mild Renal Impairment | 5.820 |
| Moderate Renal Impairment | 3.530 |
| Severe Renal Impairment | 2.658 |
| End Stage Renal Disease | 0.199 |
Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | hours (Geometric Mean) |
|---|---|
| Normal Renal Function | 13.625 |
| Mild Renal Impairment | 15.661 |
| Moderate Renal Impairment | 16.912 |
| Severe Renal Impairment | 20.224 |
| End Stage Renal Disease | 15.678 |
The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Normal Renal Function | 4.465 |
| Mild Renal Impairment | 2.737 |
| Moderate Renal Impairment | 1.424 |
| Severe Renal Impairment | 1.165 |
| End Stage Renal Disease | 0.147 |
Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | hours (Median) |
|---|---|
| Normal Renal Function | 1.000 |
| Mild Renal Impairment | 1.250 |
| Moderate Renal Impairment | 1.000 |
| Severe Renal Impairment | 1.500 |
| End Stage Renal Disease | 1.250 |
The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Normal Renal Function | 11926.796 |
| Mild Renal Impairment | 7802.955 |
| Moderate Renal Impairment | 6900.602 |
| Severe Renal Impairment | 7164.575 |
| End Stage Renal Disease | 9926.962 |
AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng*h/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 83.845 |
| Mild Renal Impairment | 128.157 |
| Moderate Renal Impairment | 144.915 |
| Severe Renal Impairment | 139.576 |
| End Stage Renal Disease | 100.736 |
Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 8.309 |
| Mild Renal Impairment | 9.762 |
| Moderate Renal Impairment | 10.206 |
| Severe Renal Impairment | 7.677 |
| End Stage Renal Disease | 7.668 |
Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation. (NCT01830205)
Timeframe: First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs
| Intervention | Participants (Number) | ||
|---|---|---|---|
| SAEs | Death | Discontinuations due to AEs | |
| End Stage Renal Disease | 0 | 0 | 0 |
| Mild/Moderate Renal Impairment | 0 | 0 | 0 |
| Mild/Severe Renal Impairment | 0 | 0 | 0 |
| Normal Renal Function/Mild Renal Impairment | 0 | 0 | 0 |
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. (NCT02207088)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA ± RBV | 0 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. (NCT02207088)
Timeframe: Within 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA ± RBV | 1.5 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA ± RBV | 94.1 |
5 reviews available for carbamates and Kidney Failure, Chronic
| Article | Year |
|---|---|
Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta-analysis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or | 2022 |
Post-translational modification derived products (PTMDPs): toxins in chronic diseases?
Topics: Carbamates; Diabetes Mellitus; Glycation End Products, Advanced; Humans; Kidney Failure, Chronic; Li | 2014 |
Protein carbamylation in kidney disease: pathogenesis and clinical implications.
Topics: Animals; Biomarkers; Carbamates; Humans; Kidney Failure, Chronic; Male; Middle Aged; Protein Process | 2014 |
Use of direct-acting agents for hepatitis C virus-positive kidney transplant candidates and kidney transplant recipients.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Genotype; Hepacivirus; Hepatitis C | 2016 |
Carbamoylation of amino acids and proteins in uremia.
Topics: Amino Acids; Animals; Carbamates; Cyanates; Diabetic Nephropathies; Enzymes; Glucose; Hormones; Huma | 2001 |
11 trials available for carbamates and Kidney Failure, Chronic
| Article | Year |
|---|---|
Efficacy and tolerability of sofosbuvir and daclatasvir for treatment of hepatitis C genotype 1 & 3 in patients undergoing hemodialysis- a prospective interventional clinical trial.
Topics: Antiviral Agents; Carbamates; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug M | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients.
Topics: Adult; Aged; Aminoisobutyric Acids; Antiviral Agents; Biopsy, Needle; Calcineurin Inhibitors; Carbam | 2019 |
Single-Dose Pharmacokinetics and Safety of Solriamfetol in Participants With Normal or Impaired Renal Function and With End-Stage Renal Disease Requiring Hemodialysis.
Topics: Adult; Aged; Carbamates; Female; Humans; Kidney; Kidney Failure, Chronic; Male; Middle Aged; Models, | 2019 |
Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug Monitoring; Female; Hepacivirus; Hepatitis C, | 2019 |
Effect of hemodialysis on pharmacokinetics of ezogabine/retigabine and its N-acetyl metabolite in patients with end stage renal disease.
Topics: Adult; Aged; Anticonvulsants; Area Under Curve; Carbamates; Female; Humans; Kidney Failure, Chronic; | 2014 |
Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment.
Topics: Antiviral Agents; Carbamates; Female; Glomerular Filtration Rate; Hepatitis C, Chronic; Humans; Imid | 2015 |
Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Chr | 2016 |
Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dose-Response Relation | 2016 |
Clinical pharmacokinetics of gabapentin after administration of gabapentin enacarbil extended-release tablets in patients with varying degrees of renal function using data from an open-label, single-dose pharmacokinetic study.
Topics: Administration, Oral; Adult; Aged; Analgesics; Anticonvulsants; Biomarkers; Biotransformation; Carba | 2012 |
Carbamylated hemoglobin: a potential marker for the adequacy of hemodialysis therapy in end-stage renal failure.
Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Biomarkers; Carbamates; Diabetes Mellitus; | 1996 |
27 other studies available for carbamates and Kidney Failure, Chronic
| Article | Year |
|---|---|
Development and Validation of a New LC-MS/MS Analytical Method for Direct-Acting Antivirals and Its Application in End-Stage Renal Disease Patients.
Topics: Adult; Anilides; Antiviral Agents; Carbamates; Chromatography, Liquid; Cyclopropanes; Drug Stability | 2020 |
Response to direct-acting antiviral agents in chronic hepatitis C patients with end-stage renal disease: a clinical experience.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2019 |
Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease.
Topics: Adult; Aged; Benzimidazoles; Carbamates; Clinical Trials as Topic; Drug Monitoring; Drug Therapy, Co | 2020 |
Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis.
Topics: Adult; Antiviral Agents; Carbamates; Drug Combinations; Drug Therapy, Combination; Genotype; Hepaciv | 2021 |
Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Egypt | 2020 |
Transplantation of kidneys from hepatitis C-positive donors into hepatitis C virus-infected recipients followed by early initiation of direct acting antiviral therapy: a single-center retrospective study.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Donor Selection; Drug Therapy, Combinatio | 2017 |
Successful treatment of chronic hepatitis C virus infection in a patient receiving daily peritoneal dialysis.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Sc | 2017 |
Safety and efficacy of sofosbuvir-based treatment of acute hepatitis C in end-stage renal disease patients undergoing haemodialysis.
Topics: Acute Disease; Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Follow- | 2018 |
Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease.
Topics: Adult; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Combination; Female | 2018 |
Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cost-Benefit Analysis; Cyclopropanes; Drug Therap | 2018 |
'Real-life' experience with direct-acting antiviral agents for hepatitis C virus in end-stage renal disease.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Drug Therapy, Combination; Femal | 2018 |
Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort.
Topics: 2-Naphthylamine; Anilides; Antihypertensive Agents; Antiviral Agents; Carbamates; Cyclopropanes; Dru | 2018 |
Three renal failure cases successfully treated with ombitasvir/paritaprevir/ritonavir for genotype 1b hepatitis C virus reinfection after liver transplantation.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Drug Monitoring; Fem | 2019 |
Efficacy of ombitasvir/paritaprevir/ritonavir/ribavirin in management of HCV genotype 4 and end-stage kidney disease.
Topics: Adult; Aged, 80 and over; Algorithms; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Co | 2019 |
Real-life results of treatment with ombitasvir, paritaprevir, dasabuvir, and ritonavir combination in patients with chronic renal failure infected with HCV in Turkey.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2019 |
Successful Treatment With Direct-Acting Antiviral Agents of Hepatitis C in Patients With End-Stage Renal Disease and Kidney Transplant Recipients.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactio | 2019 |
Carbamylation of serum albumin and erythropoietin resistance in end stage kidney disease.
Topics: Aged; Aged, 80 and over; Anemia; Biomarkers; Carbamates; Drug Resistance; Erythropoietin; Female; He | 2013 |
The Effects of Parenteral Amino Acid Therapy on Protein Carbamylation in Maintenance Hemodialysis Patients.
Topics: Amino Acids; Carbamates; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Parenteral Nutr | 2015 |
Treatment of chronic hepatitis C with direct acting antiviral agents in patients with haemophilia, end-stage liver disease and coinfected with HIV.
Topics: Adult; Antiviral Agents; Carbamates; CD4 Lymphocyte Count; Coinfection; Drug Interactions; Hemophili | 2016 |
Full-dose sofosbuvir and daclatasvir for chronic hepatitis C infection in haemodialysis patients.
Topics: Antiviral Agents; Carbamates; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazole | 2016 |
Effectiveness of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir in Hemodialysis Patients With Hepatitis C Virus Infection and Advanced Liver Fibrosis: Case Reports.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; H | 2017 |
Carbamylation of hemoglobin in renal failure and clinical aspects.
Topics: Blood Urea Nitrogen; Carbamates; Cyanates; Diabetes Mellitus; Erythrocytes; Glucose Tolerance Test; | 1984 |
Carbamoylation of glomerular and tubular proteins in patients with kidney failure: a potential mechanism of ongoing renal damage.
Topics: Amino Acids; Animals; Carbamates; Citrulline; Cyanates; Disease Progression; Fluorescent Antibody Te | 2001 |
Carbamylated hemoglobin as a therapeutic marker in hemodialysis.
Topics: Biomarkers; Blood Urea Nitrogen; Carbamates; Female; Hemoglobins; Humans; Kidney Failure, Chronic; M | 2002 |
[Studies on the modification of hormones in patients with renal failure and clinical evaluation--with reference to carbamylated ACTH and insulin].
Topics: Adrenocorticotropic Hormone; Carbamates; Chromatography, High Pressure Liquid; Humans; Insulin; Kidn | 1985 |
Carbamylation of proteins and sulfacetamide free fraction in serum in experimentally-induced high blood urea states.
Topics: Animals; Blood Proteins; Blood Urea Nitrogen; Carbamates; Creatinine; Kidney Failure, Chronic; Male; | 1985 |
Fluorescein circulation time and the treatment of hypertension in the aged.
Topics: Adult; Age Factors; Aged; Blood Circulation Time; Blood Pressure; Carbamates; Ethacrynic Acid; Femal | 1973 |