carbamates has been researched along with Kidney Failure in 23 studies
Kidney Failure: A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Clinic records were searched to identify treatment-naïve, noncirrhotic adults with acute hepatitis C (HCV viremia and a ≥10-fold elevation of serum alanine aminotransferase activity) and eGFR <30 mL/min, who had been treated with a sofosbuvir-based regimen." | 8.02 | Acute hepatitis C treatment in advanced renal failure using 8 weeks of pan-genotypic daclatasvir and reduced-dose sofosbuvir. ( Aggarwal, R; Bhadauria, DS; Goel, A; Gupta, A; Kaul, A; Rai, P; Rungta, S; Tiwari, P; Verma, A, 2021) |
| " However, its blood concentration has been reported to increase in combination with clopidogrel, an antiplatelet drug, and in patients with severe renal insufficiency." | 8.02 | Hypoglycemia during the Concomitant Use of Repaglinide and Clopidogrel in an Elderly Patient with Type 2 Diabetes and Severe Renal Insufficiency. ( Fujii, K; Hazama, Y; Kosugi, M; Miyoshi, Y; Nagata, S; Obata, Y; Takayama, K; Uehara, Y; Yamaguchi, H; Yasuda, T, 2021) |
| "Many of the treatment regimens available for hepatitis C include sofosbuvir." | 7.96 | The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. ( Afshar, B; Agah, S; Amiriani, T; Fattahi Abdizadeh, M; Fattahi, MR; Hormati, A; Khoshnia, M; Latifnia, M; Majd Jabbari, S; Maleki, I; Malekzadeh, R; Malekzadeh, Z; Mansour-Ghanaei, F; Merat, D; Merat, S; Minakari, M; Moini, M; Mokhtare, M; Poustchi, H; Roozbeh, F; Sharifi, AH; Shayesteh, AA; Shayesteh, E; Sofian, M; Sohrabi, M; Somi, MH, 2020) |
| "Treatment of Hepatitis C virus (HCV) in patients with severe renal insufficiency is cumbersome as sofosbuvir is mainly excreted by the kidneys." | 7.88 | Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency. ( De, A; Kumar, P; Kumari, S; Singh, A; Singh, V, 2018) |
| "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) |
| " It has thus been suggested that no dosage adjustment is necessary in patients with renal dysfunction." | 5.34 | [Pharmacokinetics of amprenavir in HIV-1 patients with renal insufficiency]. ( Deray, G; Izzedine, H; Janus, N; Karie, S; Launay-Vacher, V; Laville, I, 2007) |
| "Ombitasvir, paritaprevir (given with low-dose ritonavir), and dasabuvir are direct-acting antivirals (DAAs) used with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) infection." | 4.95 | Effects of Mild and Moderate Renal Impairment on Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, and Ribavirin Pharmacokinetics in Patients with Chronic HCV Infection. ( Badri, PS; Eckert, D; Menon, RM; Mensing, S; Polepally, AR, 2017) |
| "Clinic records were searched to identify treatment-naïve, noncirrhotic adults with acute hepatitis C (HCV viremia and a ≥10-fold elevation of serum alanine aminotransferase activity) and eGFR <30 mL/min, who had been treated with a sofosbuvir-based regimen." | 4.02 | Acute hepatitis C treatment in advanced renal failure using 8 weeks of pan-genotypic daclatasvir and reduced-dose sofosbuvir. ( Aggarwal, R; Bhadauria, DS; Goel, A; Gupta, A; Kaul, A; Rai, P; Rungta, S; Tiwari, P; Verma, A, 2021) |
| " However, its blood concentration has been reported to increase in combination with clopidogrel, an antiplatelet drug, and in patients with severe renal insufficiency." | 4.02 | Hypoglycemia during the Concomitant Use of Repaglinide and Clopidogrel in an Elderly Patient with Type 2 Diabetes and Severe Renal Insufficiency. ( Fujii, K; Hazama, Y; Kosugi, M; Miyoshi, Y; Nagata, S; Obata, Y; Takayama, K; Uehara, Y; Yamaguchi, H; Yasuda, T, 2021) |
| "Many of the treatment regimens available for hepatitis C include sofosbuvir." | 3.96 | The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. ( Afshar, B; Agah, S; Amiriani, T; Fattahi Abdizadeh, M; Fattahi, MR; Hormati, A; Khoshnia, M; Latifnia, M; Majd Jabbari, S; Maleki, I; Malekzadeh, R; Malekzadeh, Z; Mansour-Ghanaei, F; Merat, D; Merat, S; Minakari, M; Moini, M; Mokhtare, M; Poustchi, H; Roozbeh, F; Sharifi, AH; Shayesteh, AA; Shayesteh, E; Sofian, M; Sohrabi, M; Somi, MH, 2020) |
| "Treatment of Hepatitis C virus (HCV) in patients with severe renal insufficiency is cumbersome as sofosbuvir is mainly excreted by the kidneys." | 3.88 | Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency. ( De, A; Kumar, P; Kumari, S; Singh, A; Singh, V, 2018) |
| " Relative to normal renal function, geometric mean area under the plasma concentration-time curve from time zero to infinity increased 53%, 129%, and 339%, and mean half-life was 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) |
| "Using data from a phase III clinical trial (GIFT-I) that enrolled Japanese patients with HCV genotype 1b infection, population pharmacokinetic models were developed for the drugs that comprise the 2D regimen: paritaprevir, ombitasvir, and ritonavir." | 2.84 | Population Pharmacokinetics of Paritaprevir, Ombitasvir, and Ritonavir in Japanese Patients with Hepatitis C Virus Genotype 1b Infection. ( Gopalakrishnan, SM; Khatri, A; Menon, RM; Mensing, S; Polepally, AR, 2017) |
| "Patients with type 2 diabetes and mild or moderate impairment of renal function may be treated with repaglinide without special precautions." | 2.70 | Single- and multiple-dose pharmacokinetics of repaglinide in patients with type 2 diabetes and renal impairment. ( Abbasi, I; Hasslacher, C; Hatorp, V; Sattler, K; Schumacher, S; Sieber, J; Weise, D, 2001) |
| " While many of the second-generation DAAs are principally metabolized by the hepatic system, dosing in severe renal impairment (creatinine clearance [CrCl] <30 mL/min) or dialysis has remained questionable due to limited experience." | 2.55 | New and Emerging Evidence on the Use of Second-Generation Direct Acting Antivirals for the Treatment of Hepatitis C Virus in Renal Impairment. ( Cope, R; Friedman, ML; Sorbera, MA, 2017) |
| " Dosage adjustments are recommended in elderly patients and those with moderate and severe renal or moderate hepatic impairment." | 2.49 | Clinical pharmacokinetics of retigabine/ezogabine. ( Crean, CS; Tompson, DJ, 2013) |
| " The pharmacokinetic profile of repaglinide and the improvements in post-prandial hyperglycaemia and overall glycaemic control make repaglinide suitable for administration preprandially, with the opportunity for flexible meal arrangements, including skipped meals, without the risk of hypoglycaemia." | 2.41 | Clinical pharmacokinetics and pharmacodynamics of repaglinide. ( Hatorp, V, 2002) |
| " Here we report pharmacokinetic (PK) and safety results from two multicenter, open-label, single-dose trials evaluating revefenacin in subjects with severe renal impairment (NCT02578082) and moderate hepatic impairment (NCT02581592)." | 1.51 | Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function. ( Barnes, CN; Borin, MT; Bourdet, DL; Lo, A; Pendyala, S, 2019) |
| "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) |
| " We evaluated the 12-week sustained virologic response (SVR12) and adverse events during treatment." | 1.43 | Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C. ( Furuya, K; Horimoto, H; Izumi, T; Kimura, M; Kobayashi, T; Konno, J; Kudo, M; Morikawa, K; Nagasaka, A; Nakai, M; Natsuizaka, M; Ogawa, K; Sakamoto, N; Sato, F; Shinada, K; Sho, T; Suda, G; Tateyama, M; Terashita, K; Tsukuda, Y; Tsunematsu, S; Umemura, M; Yamamoto, Y; Yamasaki, K, 2016) |
| " It has thus been suggested that no dosage adjustment is necessary in patients with renal dysfunction." | 1.34 | [Pharmacokinetics of amprenavir in HIV-1 patients with renal insufficiency]. ( Deray, G; Izzedine, H; Janus, N; Karie, S; Launay-Vacher, V; Laville, I, 2007) |
| "The four lenses from the renal failure patients were searched for evidence of carbamylation at lysyl or cysteinyl residues: carbamylation was not detected." | 1.29 | Glutathione adducts, not carbamylated lysines, are the major modification of lens alpha-crystallins from renal failure patients. ( Miesbauer, LR; Schwedler, J; Shun-Shin, GA; Smith, DL; Smith, JB; Sun, Y; Yang, Z; Zhou, X, 1995) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 2 (8.70) | 18.2507 |
| 2000's | 3 (13.04) | 29.6817 |
| 2010's | 15 (65.22) | 24.3611 |
| 2020's | 3 (13.04) | 2.80 |
| Authors | Studies |
|---|---|
| Ngo, P | 1 |
| Bycroft, R | 1 |
| Borin, MT | 1 |
| Lo, A | 1 |
| Barnes, CN | 1 |
| Pendyala, S | 1 |
| Bourdet, DL | 1 |
| Poustchi, H | 1 |
| Majd Jabbari, S | 1 |
| Merat, S | 1 |
| Sharifi, AH | 1 |
| Shayesteh, AA | 1 |
| Shayesteh, E | 1 |
| Minakari, M | 1 |
| Fattahi, MR | 1 |
| Moini, M | 1 |
| Roozbeh, F | 1 |
| Mansour-Ghanaei, F | 1 |
| Afshar, B | 1 |
| Mokhtare, M | 1 |
| Amiriani, T | 1 |
| Sofian, M | 1 |
| Somi, MH | 1 |
| Agah, S | 1 |
| Maleki, I | 1 |
| Latifnia, M | 1 |
| Fattahi Abdizadeh, M | 1 |
| Hormati, A | 1 |
| Khoshnia, M | 1 |
| Sohrabi, M | 1 |
| Malekzadeh, Z | 1 |
| Merat, D | 1 |
| Malekzadeh, R | 1 |
| Goel, A | 1 |
| Bhadauria, DS | 1 |
| Kaul, A | 1 |
| Verma, A | 1 |
| Tiwari, P | 1 |
| Rungta, S | 1 |
| Rai, P | 1 |
| Gupta, A | 1 |
| Aggarwal, R | 1 |
| Takayama, K | 1 |
| Fujii, K | 1 |
| Yamaguchi, H | 1 |
| Miyoshi, Y | 1 |
| Uehara, Y | 1 |
| Nagata, S | 1 |
| Obata, Y | 1 |
| Kosugi, M | 1 |
| Hazama, Y | 1 |
| Yasuda, T | 1 |
| Sperl, J | 1 |
| Kreidlova, M | 1 |
| Merta, D | 1 |
| Chmelova, K | 1 |
| Senkerikova, R | 1 |
| Frankova, S | 1 |
| Singh, A | 1 |
| Kumari, S | 1 |
| Kumar, P | 1 |
| De, A | 1 |
| Singh, V | 1 |
| Zomorodi, K | 1 |
| Chen, D | 1 |
| Lee, L | 1 |
| Lasseter, K | 1 |
| Marbury, T | 1 |
| Post, FA | 1 |
| Winston, J | 1 |
| Andrade-Villanueva, JF | 1 |
| Fisher, M | 1 |
| Liu, Y | 1 |
| Beraud, C | 1 |
| Abram, ME | 1 |
| Graham, H | 1 |
| Rhee, MS | 1 |
| Cheng, AK | 1 |
| Szwarcberg, J | 1 |
| Suda, G | 1 |
| Kudo, M | 1 |
| Nagasaka, A | 1 |
| Furuya, K | 1 |
| Yamamoto, Y | 1 |
| Kobayashi, T | 1 |
| Shinada, K | 1 |
| Tateyama, M | 1 |
| Konno, J | 1 |
| Tsukuda, Y | 1 |
| Yamasaki, K | 1 |
| Kimura, M | 1 |
| Umemura, M | 1 |
| Izumi, T | 1 |
| Tsunematsu, S | 1 |
| Sato, F | 1 |
| Terashita, K | 1 |
| Nakai, M | 1 |
| Horimoto, H | 1 |
| Sho, T | 1 |
| Natsuizaka, M | 1 |
| Morikawa, K | 1 |
| Ogawa, K | 1 |
| Sakamoto, N | 1 |
| Sorbera, MA | 1 |
| Friedman, ML | 1 |
| Cope, R | 1 |
| Verheul, MK | 1 |
| van Erp, SJ | 1 |
| van der Woude, D | 1 |
| Levarht, EW | 1 |
| Mallat, MJ | 1 |
| Verspaget, HW | 1 |
| Stolk, J | 1 |
| Toes, RE | 1 |
| van der Meulen-de Jong, AE | 1 |
| Hiemstra, PS | 1 |
| van Kooten, C | 1 |
| Trouw, LA | 1 |
| Polepally, AR | 2 |
| Badri, PS | 1 |
| Eckert, D | 1 |
| Mensing, S | 2 |
| Menon, RM | 2 |
| Smolders, EJ | 1 |
| Kanter, CT | 1 |
| Grintjes, K | 1 |
| D'Avolio, A | 1 |
| Di Perri, G | 1 |
| van Crevel, R | 1 |
| Drenth, JP | 1 |
| Burger, DM | 1 |
| Beinhardt, S | 1 |
| Al Zoairy, R | 1 |
| Ferenci, P | 1 |
| Kozbial, K | 1 |
| Freissmuth, C | 1 |
| Stern, R | 1 |
| Stättermayer, AF | 1 |
| Stauber, R | 1 |
| Strasser, M | 1 |
| Zoller, H | 1 |
| Watschinger, B | 1 |
| Schmidt, A | 1 |
| Trauner, M | 1 |
| Hofer, H | 1 |
| Maieron, A | 1 |
| Gopalakrishnan, SM | 1 |
| Khatri, A | 1 |
| Ishigami, M | 1 |
| Hayashi, K | 1 |
| Honda, T | 1 |
| Kuzuya, T | 1 |
| Ishizu, Y | 1 |
| Ishikawa, T | 1 |
| Nakano, I | 1 |
| Urano, F | 1 |
| Kumada, T | 1 |
| Yoshioka, K | 1 |
| Goto, H | 1 |
| Hirooka, Y | 1 |
| Tompson, DJ | 1 |
| Crean, CS | 1 |
| Janus, N | 1 |
| Launay-Vacher, V | 1 |
| Izzedine, H | 1 |
| Karie, S | 1 |
| Laville, I | 1 |
| Deray, G | 1 |
| Smith, JB | 1 |
| Shun-Shin, GA | 1 |
| Sun, Y | 1 |
| Miesbauer, LR | 1 |
| Yang, Z | 2 |
| Zhou, X | 1 |
| Schwedler, J | 1 |
| Smith, DL | 1 |
| Frazao, JM | 1 |
| Barth, RH | 1 |
| Berlyne, GM | 1 |
| Schumacher, S | 1 |
| Abbasi, I | 1 |
| Weise, D | 1 |
| Hatorp, V | 2 |
| Sattler, K | 1 |
| Sieber, J | 1 |
| Hasslacher, C | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208[NCT02581592] | Phase 1 | 16 participants (Actual) | Interventional | 2015-11-30 | Completed | ||
| The Effect of Severe Renal Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD 4208[NCT02578082] | Phase 1 | 16 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
| Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.[NCT03063879] | Phase 4 | 95 participants (Actual) | Interventional | 2017-04-01 | Completed | ||
| A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment[NCT01363011] | Phase 3 | 106 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
| Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Se[NCT00235755] | Phase 3 | 539 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| E/C/F/TDF (Cohort 1) | 84.8 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| COBI+PI+2 NRTIs (Cohort 2) | 90.4 |
Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance. (NCT01363011)
Timeframe: Baseline; Weeks 2, 4, and 24
| Intervention | mL/min (Number) | |||
|---|---|---|---|---|
| Baseline | Change at Week 2 | Change at Week 4 | Change at Week 24 | |
| E/C/F/TDF (Cohort 1) | 81.6 | -12.1 | -7.3 | -3.3 |
Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance. (NCT01363011)
Timeframe: Baseline; Weeks 2, 4, and 24
| Intervention | mL/min (Median) | |||
|---|---|---|---|---|
| Baseline | Change at Week 2 (n=13) | Change at Week 4 (n=13) | Change at Week 24 (n=11) | |
| COBI+PI+2 NRTIs (Cohort 2) | 82.5 | 1.6 | 7.0 | -4.1 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Baseline (n = 33) | Change at Week 24 (n = 30) | |
| E/C/F/TDF (Cohort 1) | 77.6 | 0.3 |
Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Baseline (n = 33) | Change at Week 24 (n = 30) | |
| E/C/F/TDF (Cohort 1) | 77.1 | -7.4 |
Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min (Median) | |
|---|---|---|
| Baseline (n = 73) | Change at Week 24 (n = 67) | |
| COBI+PI+2 NRTIs (Cohort 2) | 71.4 | -3.7 |
Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96
| Intervention | mL/min (Median) | |
|---|---|---|
| Change at Week 48 (n = 28) | Change at Week 96 (n = 25) | |
| E/C/F/TDF (Cohort 1) | -7.6 | -7.9 |
Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Week 48
| Intervention | mL/min (Median) | |
|---|---|---|
| Change at Week 48 (n = 63) | Change at Week 96 (n = 50) | |
| COBI+PI+2 NRTIs (Cohort 2) | -3.8 | -5.0 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Change at Week 48 (n = 28) | Change at Week 96 (n = 25) | |
| E/C/F/TDF (Cohort 1) | 1.6 | 12.6 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Change at Week 48 (n = 63) | Change at Week 96 (n = 50) | |
| COBI+PI+2 NRTIs (Cohort 2) | -4.7 | -2.8 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Change at Week 48 (n = 28) | Change at Week 96 (n = 25) | |
| E/C/F/TDF (Cohort 1) | 1.9 | 12.4 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Change at Week 48 (n = 63) | Change at Week 96 (n = 50) | |
| COBI+PI+2 NRTIs (Cohort 2) | -4.7 | -2.4 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Baseline (n = 33) | Change at Week 24 (n = 30) | |
| E/C/F/TDF (Cohort 1) | 76.9 | 0.3 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Baseline (n = 73) | Change at Week 24 (n = 67) | |
| COBI+PI+2 NRTIs (Cohort 2) | 78.2 | -2.8 |
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Baseline (n = 73) | Change at Week 24 (n = 67) | |
| COBI+PI+2 NRTIs (Cohort 2) | 78.6 | -2.7 |
Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Baseline (n = 73) | Change at Week 24 (n = 67) | |
| COBI+PI+2 NRTIs (Cohort 2) | 65.8 | -3.4 |
Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Change at Week 48 (n = 28) | Change at Week 96 (n = 25) | |
| E/C/F/TDF (Cohort 1) | -12.1 | -12.9 |
Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96
| Intervention | mL/min/1.73 m^2 (Median) | |
|---|---|---|
| Change at Week 48 (n = 63) | Change at Week 96 (n = 50) | |
| COBI+PI+2 NRTIs (Cohort 2) | -3.9 | -2.8 |
Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive). (NCT01363011)
Timeframe: Baseline; Week 24
| Intervention | mL/min (Median) | |
|---|---|---|
| Baseline (n = 33) | Change at Week 24 (n = 30) | |
| E/C/F/TDF (Cohort 1) | 72.9 | -5.2 |
Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 147 weeks plus 30 days
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Any AE | Drug-related AE | Grade 3 or higher AE | AE leading to drug discontinuation | Serious AE | AE of proximal renal tubulopathy | |
| E/C/F/TDF (Cohort 1) | 100.0 | 48.5 | 21.2 | 12.1 | 18.2 | 0 |
Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 166 weeks plus 30 days
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Any AE | Drug-related AE | Grade 3 or higher AE | AE leading to drug discontinuation | Serious AE | AE of proximal renal tubulopathy | |
| COBI+PI+2 NRTIs (Cohort 2) | 93.2 | 27.4 | 28.8 | 11.0 | 15.1 | 0 |
Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 147 weeks plus 30 days
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Any laboratory abnormality | Grade 3 or 4 laboratory abnormality | |
| E/C/F/TDF (Cohort 1) | 100.0 | 39.4 |
Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 166 weeks plus 30 days
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Any laboratory abnormality | Grade 3 or 4 laboratory abnormality | |
| COBI+PI+2 NRTIs (Cohort 2) | 100.00 | 50.0 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Weeks 48 and 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 48 (n = 33) | Week 96 (n = 27) | |
| E/C/F/TDF (Cohort 1) | 78.8 | 88.9 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Weeks 48 and 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 48 (n = 73) | Week 96 (n = 54) | |
| COBI+PI+2 NRTIs (Cohort 2) | 82.2 | 90.7 |
AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | h*ng/mL (Number) | ||
|---|---|---|---|
| Week 2 | Week 4 | Week 24 | |
| E/C/F/TDF (Cohort 1) | 16554.7 | 12704.1 | 9799.7 |
AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | h*ng/mL (Mean) | ||
|---|---|---|---|
| Week 2 (n = 13) | Week 4 (n = 13) | Week 24 (n = 11) | |
| COBI+PI+2 NRTIs (Cohort 2) | 12458.0 | 11165.3 | 13980.5 |
Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | ng/mL (Number) | ||
|---|---|---|---|
| Week 2 | Week 4 | Week 24 | |
| E/C/F/TDF (Cohort 1) | 1734.6 | 1522.9 | 1266.4 |
Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | ng/mL (Mean) | ||
|---|---|---|---|
| Week 2 (n = 13) | Week 4 (n = 13) | Week 24 (n = 11) | |
| COBI+PI+2 NRTIs (Cohort 2) | 1366.7 | 1297.7 | 1568.6 |
Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | ng/mL (Number) | ||
|---|---|---|---|
| Week 2 | Week 4 | Week 24 | |
| E/C/F/TDF (Cohort 1) | 150.5 | 37.3 | 24.2 |
Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | ng/mL (Mean) | ||
|---|---|---|---|
| Week 2 (n = 13) | Week 4 (n = 13) | Week 24 (n = 11) | |
| COBI+PI+2 NRTIs (Cohort 2) | 79.9 | 71.3 | 139.8 |
t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | hours (Number) | ||
|---|---|---|---|
| Week 2 | Week 4 | Week 24 | |
| E/C/F/TDF (Cohort 1) | 6.14 | 3.57 | 3.63 |
t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | hours (Median) | ||
|---|---|---|---|
| Week 2 (n = 13) | Week 4 (n = 12) | Week 24 (n = 10) | |
| COBI+PI+2 NRTIs (Cohort 2) | 4.37 | 3.98 | 3.77 |
Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | hours (Number) | ||
|---|---|---|---|
| Week 2 | Week 4 | Week 24 | |
| E/C/F/TDF (Cohort 1) | 4.00 | 2.00 | 4.00 |
Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.
| Intervention | hours (Median) | ||
|---|---|---|---|
| Week 2 (n = 13) | Week 4 (n = 13) | Week 24 (n = 11) | |
| COBI+PI+2 NRTIs (Cohort 2) | 3.92 | 4.92 | 3.00 |
Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00235755)
Timeframe: Week 16/end of treatment phase
| Intervention | scores on a scale (Mean) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 3.2 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 2.9 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 2.9 |
PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00235755)
Timeframe: Week 16/end of treatment phase
| Intervention | scores on a scale (Mean) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 3.3 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 2.9 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 3.0 |
28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 5 through Week 16
| Intervention | Percent change in seizure frequency (Median) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | -17.4 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | -35.3 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | -44.3 |
28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)
| Intervention | percent change in seizure frequency (Median) |
|---|---|
| Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) | -15.9 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | -39.9 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | -27.9 |
A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | percentage of days (Median) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 77.8 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 79.5 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 82.1 |
A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%. (NCT00235755)
Timeframe: Week 5 through Week 16
| Intervention | percentage of days (Median) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 78.1 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 81.6 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 84.5 |
Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline. (NCT00235755)
Timeframe: Baseline (Week -7 through 0), Weeks 8 and 16
| Intervention | milliliters (Median) | |
|---|---|---|
| Week 8, n=143, 134, 121 | Week 16, n=141, 131, 115 | |
| Placebo: Maintenance Phase | 0 | 0 |
| Retigabine 200 mg TID: Maintenance Phase | 0 | 0 |
| Retigabine 300 mg TID: Maintenance Phase | 0 | 0 |
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period. (NCT00235755)
Timeframe: Week 5 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Responders | Non-responders | |
| Placebo - DB Phase (Titration Plus Maintenance) | 31 | 133 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance | 61 | 97 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 70 | 79 |
New seizure types included those seizures which were not reported by any participant at Baseline. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 16
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Partial seizures without motor signs | Partial evolving to secondarily generalized | Partial seizures with motor signs | Tonic-clonic seizures | Flurries | Tonic seizures | Complex partial seizures | Unclassified seizures | |
| Placebo - DB Phase (Titration Plus Maintenance) | 9 | 6 | 5 | 0 | 3 | 3 | 1 | 0 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 8 | 5 | 6 | 0 | 2 | 0 | 4 | 1 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 12 | 9 | 3 | 3 | 1 | 1 | 4 | 0 |
Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 5 through Week 16
| Intervention | participants (Number) | ||
|---|---|---|---|
| 0% to 25% increase | >=25% increase | >0% reduction | |
| Placebo - DB Phase (Titration Plus Maintenance) | 28 | 22 | 114 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 14 | 23 | 121 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 11 | 19 | 119 |
A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Dysuria | Urinary retention | Polyuria | Urinary hesitation | Haematuria | |
| Placebo - DB Phase (Titration Plus Maintenance) | 0 | 0 | 4 | 3 | 2 |
| Placebo - Transition Phase | 0 | 0 | 0 | 3 | 1 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 3 | 1 | 1 | 6 | 5 |
| Retigabine 200 mg TID - Transition Phase | 0 | 0 | 0 | 1 | 0 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 4 | 4 | 2 | 1 | 2 |
| Retigabine 300 mg TID - Transition Phase | 0 | 0 | 0 | 0 | 1 |
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Responders | Non-responders | |
| Placebo - DB Phase (Titration Plus Maintenance) | 31 | 148 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 57 | 124 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 70 | 108 |
Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Seizure-free | Not seizure-free | |
| Placebo - DB Phase (Titration Plus Maintenance) | 2 | 174 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 0 | 179 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 7 | 168 |
Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase. (NCT00235755)
Timeframe: Week 5 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Seizure-free | Not seizure-free | |
| Placebo - DB Phase (Titration Plus Maintenance) | 2 | 162 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 5 | 153 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 7 | 142 |
Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Protenuria | Hyperlipidemia | Hypercholesterolemia | Hematuria | |
| Placebo - DB Phase (Titration Plus Maintenance) | 3 | 3 | 2 | 2 |
| Placebo - Transition Phase | 0 | 0 | 0 | 1 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 2 | 0 | 4 | 5 |
| Retigabine 200 mg TID - Transition Phase | 1 | 0 | 0 | 0 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 0 | 0 | 1 | 2 |
| Retigabine 300 mg TID - Transition Phase | 0 | 0 | 1 | 1 |
The number of participants with recorded weight gain of >=7% over their baseline weight was measured. (NCT00235755)
Timeframe: Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 2, n=174, 180, 175 | Week 4, n=169, 172, 167 | Week 6, n=169, 165, 152 | Week 8, n=161, 160, 149 | Week 12, n=159, 151, 144 | Week 16, n=153, 139, 132 | |
| Placebo - DB Phase (Titration Plus Maintenance) | 0 | 0 | 1 | 1 | 6 | 4 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 3 | 7 | 8 | 9 | 15 | 13 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 3 | 8 | 7 | 7 | 13 | 12 |
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 16
| Intervention | participants (Number) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reduction: 90% to 100% | Reduction: 80% to <90% | Reduction: 70% to <80% | Reduction: 60% to <70% | Reduction: 50% to <60% | Reduction: 40% to <50% | Reduction: 30% to <40% | Reduction: 20% to <30% | Reduction: 10% to <20% | Reduction: >0% to <10% | Increase: 0% to 10% | Increase: >10% to 20% | Increase: >20% to 30% | Increase: >30% | |
| Placebo - DB Phase (Titration Plus Maintenance) | 3 | 4 | 8 | 7 | 9 | 9 | 15 | 24 | 18 | 16 | 20 | 13 | 8 | 25 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 5 | 8 | 11 | 14 | 19 | 13 | 16 | 16 | 18 | 13 | 11 | 9 | 3 | 25 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 11 | 14 | 7 | 21 | 17 | 17 | 21 | 9 | 10 | 8 | 11 | 7 | 1 | 24 |
"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the No reduction category." (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 16
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| 75% to 100% reduction | 50% to <75% reduction | 25% to <50% reduction | >0 to <25% reduction | No reduction | |
| Placebo - DB Phase (Titration Plus Maintenance) | 12 | 19 | 39 | 43 | 66 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 16 | 41 | 38 | 38 | 48 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 27 | 43 | 41 | 24 | 43 |
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint). (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 5 through Week 16
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| >75% reduction | 50% to 75% reduction | >0 to <50% reduction | No reduction | |
| Placebo - DB Phase (Titration Plus Maintenance) | 11 | 20 | 83 | 50 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 27 | 34 | 60 | 37 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 30 | 40 | 49 | 30 |
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores. (NCT00235755)
Timeframe: End of Baseline (Week 0), Weeks 4, 8, and 16
| Intervention | scores on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline, n=165, 173, 166 | Week 4 (Titration Phase), n=155, 155, 149) | Week 8 (Maintenance Phase), n=141, 146, 127 | Week 16 (Maintenance Phase), n=143, 133, 123 | |
| Placebo - DB Phase (Titration Plus Maintenance) | 53.3 | 55.4 | 55.3 | 54.7 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 56.0 | 57.3 | 59.6 | 59.1 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 52.1 | 52.7 | 52.7 | 53.2 |
4 reviews available for carbamates and Kidney Failure
| Article | Year |
|---|---|
New and Emerging Evidence on the Use of Second-Generation Direct Acting Antivirals for the Treatment of Hepatitis C Virus in Renal Impairment.
Topics: Amides; Animals; Antiviral Agents; Carbamates; Cyclopropanes; Hepacivirus; Hepatitis C; Hepatitis C, | 2017 |
Effects of Mild and Moderate Renal Impairment on Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, and Ribavirin Pharmacokinetics in Patients with Chronic HCV Infection.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Area Under Curve; Carbamates; | 2017 |
Clinical pharmacokinetics of retigabine/ezogabine.
Topics: Age Factors; Aged; Anticonvulsants; Biological Availability; Carbamates; Clinical Trials as Topic; D | 2013 |
Clinical pharmacokinetics and pharmacodynamics of repaglinide.
Topics: Adult; Aged; Blood Glucose; Carbamates; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dose-Re | 2002 |
3 trials available for carbamates and Kidney Failure
| Article | Year |
|---|---|
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 |
Population Pharmacokinetics of Paritaprevir, Ombitasvir, and Ritonavir in Japanese Patients with Hepatitis C Virus Genotype 1b Infection.
Topics: Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Double-Blind Method; | 2017 |
Single- and multiple-dose pharmacokinetics of repaglinide in patients with type 2 diabetes and renal impairment.
Topics: Aged; Analysis of Variance; Area Under Curve; Carbamates; Diabetes Mellitus, Type 2; Dose-Response R | 2001 |
16 other studies available for carbamates and Kidney Failure
| Article | Year |
|---|---|
Encorafenib and binimetinib for the treatment of BRAF-mutated metastatic melanoma in the setting of combined hepatic and renal impairment.
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Humans; Liver Neoplasms; | 2019 |
Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzamides; Carbamates; Female; Hepatic Insufficiency; H | 2019 |
Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzamides; Carbamates; Female; Hepatic Insufficiency; H | 2019 |
Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzamides; Carbamates; Female; Hepatic Insufficiency; H | 2019 |
Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzamides; Carbamates; Female; Hepatic Insufficiency; H | 2019 |
The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C; Humans; Imidazoles; Li | 2020 |
Acute hepatitis C treatment in advanced renal failure using 8 weeks of pan-genotypic daclatasvir and reduced-dose sofosbuvir.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; | 2021 |
Hypoglycemia during the Concomitant Use of Repaglinide and Clopidogrel in an Elderly Patient with Type 2 Diabetes and Severe Renal Insufficiency.
Topics: Aged; Blood Glucose; Carbamates; Clopidogrel; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypog | 2021 |
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 |
Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Carbamates; Female; Fl | 2018 |
Elvitegravir/cobicistat/emtricitabine/tenofovir DF in HIV-infected patients with mild-to-moderate renal impairment.
Topics: Adenine; Adult; Anti-HIV Agents; Carbamates; Cobicistat; Cohort Studies; Deoxycytidine; Emtricitabin | 2015 |
Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; Humans; | 2016 |
Anti-carbamylated protein antibodies: a specific hallmark for rheumatoid arthritis. Comparison to conditions known for enhanced carbamylation; renal failure, smoking and chronic inflammation.
Topics: Adult; Aged; Animals; Arthritis, Rheumatoid; Autoantibodies; Autoantigens; Biomarkers; Carbamates; C | 2016 |
Sixty milligram daclatasvir is the right dose for hepatitis C virus treatment in combination with etravirine and darunavir/ritonavir.
Topics: Anti-HIV Agents; Antiviral Agents; Area Under Curve; Carbamates; Coinfection; Darunavir; Diuretics; | 2016 |
DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Drug Therapy, Combination | 2016 |
Real World Data of Daclatasvir and Asunaprevir Combination Therapy for HCV Genotype 1b Infection in Patients With Renal Dysfunction.
Topics: Antiviral Agents; Carbamates; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Dru | 2017 |
[Pharmacokinetics of amprenavir in HIV-1 patients with renal insufficiency].
Topics: Acquired Immunodeficiency Syndrome; Adult; Anti-HIV Agents; Carbamates; Female; Furans; Humans; Kidn | 2007 |
Glutathione adducts, not carbamylated lysines, are the major modification of lens alpha-crystallins from renal failure patients.
Topics: Aged; Aged, 80 and over; Aging; Carbamates; Crystallins; Female; Glutathione; Guanidine; Guanidines; | 1995 |
Carbamylated hemoglobin in prerenal azotemia.
Topics: Aged; Aged, 80 and over; Blood Urea Nitrogen; Carbamates; Creatinine; Diagnosis, Differential; Femal | 1995 |