Clinical trials: Renal Insufficiency
Infections, Bacterial
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required.
- Trial name
- NCT02729038
- Testing
- Gepotidacin
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Renal Insufficiency, Type 2 Diabetes Mellitus
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3…
- Trial name
- NCT01407276
- Testing
- Omarigliptin
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Anemia Associated With Chronic Kidney Disease (CKD)
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of…
- Trial name
- NCT04707768
- Testing
- Vadadustat, Mircera®
- Where
- 58 sites in United States
- Volunteers
- 456 people
- Sponsor
- Akebia Therapeutics
Tumors
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of…
- Trial name
- NCT00113113
- Testing
- Rubitecan
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function
This is an open-label study that will measure blood levels of different parts of a drug called GKS189075. People participating in this study will receive a single dose of 250mg GSK189075 by mouth.
- Conditions
- Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2, Renal Insufficiency
- Trial name
- NCT00501462
- Testing
- GSK189075
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
CKD Stage 3, CKD Stage 4
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D…
- Conditions
- CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism, VDI
- Trial name
- NCT07494045
- Testing
- CTAP101
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- OPKO Health, Inc.
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package…
- Trial name
- NCT00584779
- Testing
- Gabapentin
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Renal Impairment
Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals…
- Trial name
- NCT01526746
- Testing
- Tasimelteon
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Chronic Renal Failure, Chronic Kidney Disease
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA)…
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- PEARL 1 (NCT00598273)
- Testing
- peginesatide, Darbepoetin alfa
- Where
- 72 sites in United States, Puerto Rico
- Volunteers
- 490 people
- Sponsor
- Affymax
Hemodialysis Access
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.
- Trial name
- NCT00479180
- Testing
- Vascugel
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Pervasis Therapeutics, Inc
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow…
- Trial name
- NCT01894256
- Testing
- Olaparib tablet dosing
- Where
- 13 sites in Belgium, Denmark and 3 more
- Volunteers
- 56 people
- Sponsor
- AstraZeneca
Renal Insufficiency, Chronic
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by…
- Trial name
- NCT00596518
- Testing
- PF-00734200
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.
- Trial name
- NCT07559396
- Testing
- INCB123667
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Incyte Corporation
IgA Nephropathy, Membranous Nephropathy
IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients
IM19 CAR-T cell therapy for IgA nephropathy patients with urinary protein and renal dysfunction, as well as patients with intermediate to high-risk primary membranous nephropathy
- Trial name
- NCT06690359
- Testing
- IM19 chimeric antigen receptor T cell injection
- Volunteers
- 12 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Renal Disease, End Stage Renal Disease
A Multi-Center, Open-Label Study
This study will be an open-label, single-treatment, single-dose, parallel group study to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and End Stage Renal Disease…
- Trial name
- NCT01468259
- Testing
- Droxidopa
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Chelsea Therapeutics
Acute Myocardial Infarction, Moderate Renal Impairment
A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction
This study is a phase 2, multicenter, double-blind, randomized, placebo controlled, parallel-group study to investigate the renal safety and tolerability of multiple dose intravenous (IV) administration of CSL112 compared with…
- Trial name
- NCT02742103
- Testing
- CSL_112
- Where
- 31 sites in United States, Germany and 3 more
- Volunteers
- 83 people
- Sponsor
- CSL Behring
Kidney Transplant Rejection
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
- Trial name
- NCT05983770
- Testing
- AT-1501, Tacrolimus
- Where
- 43 sites in United States, Australia and 5 more
- Volunteers
- 127 people
- Sponsor
- Eledon Pharmaceuticals
Secondary Hyperparathyroidism, Renal Failure
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who…
- Conditions
- Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency
- Trial name
- NCT00123461
- Testing
- Hectorol (doxercalciferol capsules), 0.5mcg
- Where
- 19 sites in United States, Puerto Rico
- Volunteers
- 70 people
- Sponsor
- Genzyme, a Sanofi Company
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- W.L.Gore & Associates
Participants With Moderate and Severe Renal Impairment and Healthy Participants
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
- Trial name
- NCT07797322
- Testing
- PKN605
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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