Clinical trials: CKD Stage 5
Renal Impairment
Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD
This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.
- Trial name
- NCT04565171
- Testing
- Yimitasvir Phosphate Capsule
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Renal Impairment, Renal Disease
Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function
Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal…
- Trial name
- NCT04810598
- Testing
- Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AbbVie
Renal Impairment
A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
- Trial name
- NCT06318676
- Testing
- Mezigdomide
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Celgene
End Stage Renal Disease
Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
This is a Phase 1, open-label, three-period sequential dosing study being conducted to determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy adults.
- Trial name
- RMFPC-12 (NCT02636049)
- Testing
- Triferic
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Rockwell Medical Technologies, Inc.
Renal Insufficiency, Kidney Disease
A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.
The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end…
- Trial name
- NCT02325024
- Testing
- Sativex
- Volunteers
- healthy volunteers welcome
- Sponsor
- GW Pharmaceuticals Ltd
Healthy
Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension
To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with varying degrees of renal impairment
- Trial name
- NCT00637403
- Testing
- Megestrol acetate concentrated suspension 125 mg/mL
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Hemodialysis, Healthy
Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects
The objectives of this study are to evaluate the in vivo metabolite profiling and characterization of CR845 administered intravenously (IV) in patients on hemodialysis (HD) and in healthy subjects; and to determine the…
- Trial name
- NCT03947970
- Testing
- [14C] CR845
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cara Therapeutics, Inc.
Renal Insufficiency, End Stage Renal Disease
A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function
The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
- Trial name
- NCT03482024
- Testing
- Tirzepatide
- Where
- 4 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Endometriosis Related Pain, Overactive Bladder
Study on the Safety of BAY1817080 How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given to Participants With Moderate Renal Impairment and End Stage Renal Disease Requiring Dialysis Compared With Matched Participants With Normal Renal Function
BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the…
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04471337
- Testing
- BAY1817080
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Impairment
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.
- Trial name
- NCT01459250
- Testing
- AGO178C
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Failure, Chronic, End-Stage Renal Disease
PK of Serelaxin in Severe Renal Impairment and ESRD
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD)…
- Trial name
- CRLX030A2102 (NCT01875523)
- Testing
- Serelaxin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Insufficiency
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal…
- Trial name
- NCT01715259
- Testing
- Abiraterone acetate: participants with end-stage renal disease, Abiraterone acetate: matched control participants with normal renal function
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
End Stage Renal Disease, Renal Impairment
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD)…
- Trial name
- NCT04994522
- Testing
- Belzutifan
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Renal Impairment, Healthy Volunteer
A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
- Trial name
- NCT03890770
- Testing
- BMS-986165
- Where
- 6 sites in United States, Czechia and 2 more
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
End Stage Renal Disease
To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants.
The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerability of AZD8233 in male and female participants with severe renal impairment and…
- Trial name
- NCT05065463
- Testing
- AZD8233
- Where
- Poland
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers, Renal Failure
Pharmacokinetics in End Stage Renal Disease Patients
The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease…
- Trial name
- NCT04792333
- Testing
- firibastat
- Where
- France
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Quantum Genomics SA
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
Healthy Volunteers
Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548
The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.
- Trial name
- NCT02327546
- Testing
- AKB-6548, Ferrous Sulfate
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Renal Insufficiency
Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects
The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population.
- Trial name
- NCT03087942
- Testing
- QAW039, QAW39A, QAW39A2107
- Where
- 2 sites in United States, Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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