Clinical trials: Dialysis
Normal Renal Function, Impaired Renal Function
A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function
For subjects with normal renal function or severely impaired renal function, this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine.
- Trial name
- NCT02965040
- Testing
- Roxadustat
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
End Stage Renal Disease on Dialysis, Adult
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
This study will evaluate how fosmanogepix is processed by the body (pharmacokinetics, PK) in participants with kidney failure (end-stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) compared with participants…
- Trial name
- NCT07916181
- Testing
- Intravenous fosmanogepix
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
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
Healthy
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered…
- Trial name
- NCT02412449
- Testing
- AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state., AKB-6548 tablet, test formulation given in the fed state
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Renal Insufficiency, Healthy
A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to…
- Trial name
- NCT01759576
- Testing
- Canagliflozin (JNJ-28431754)
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Constipation, Peritoneal Dialysis (PD)
Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.
This is a randomized controlled clinical study realized in the nephrology service of the Centro Medico ISSEMyM hospital in Metepec, State of Mexico, including new patients on Peritoneal Dialysis (PD) over 18 years of age with…
- Conditions
- Constipation, Peritoneal Dialysis (PD), CKD, Quality of Life (QOL)
- Trial name
- NCT06738550
- Testing
- inulin, Lactulose oral solution
- Where
- Mexico
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- NIN Institute
Renal Insufficiency
Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function
The purpose of this study is to evaluate tirofiban concentration in the blood over a period of 24 hours after tirofiban administration. Subjects with varying degrees of renal insufficiency (i.e.
- Trial name
- NCT01766154
- Testing
- Tirofiban
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medicure
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.
Known Androgen Deficiency
Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men
Low testosterone is a common male problem. The diagnosis of low testosterone often requires blood sampling and expensive testing. We want to know if measuring saliva testosterone can be used in place of blood sampling.
- Trial name
- NCT01909505
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Saliva Biomarkers, Inc.
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, Chronic
To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects
The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and…
- Trial name
- NCT02312973
- Testing
- Molidustat(BAY85-3934)
- Where
- 2 sites in Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bayer
Dialysis, Healthy Subjects
An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients
The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers…
- Conditions
- Dialysis, Healthy Subjects, Cytomegalovirus Infection
- Trial name
- NCT02103426
- Testing
- ASP0113
- Where
- 4 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Renal Impairment, Healthy Volunteers
A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of…
- Trial name
- NCT03296787
- Testing
- TAK-954
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy, Renal Impairment
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects
To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects.
- Trial name
- NCT01796938
- Testing
- Lacosamide tablet
- Where
- 2 sites in Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- UCB BIOSCIENCES GmbH
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
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
Hyperphosphatemia
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.
- Trial name
- NCT06206135
- Testing
- the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)
- Where
- South Korea
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- LG Chem
Staphylococcal Skin Infections, Streptococcal Infections
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single…
- Trial name
- NCT01030731
- Testing
- Ceftobiprole
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Renal Impairment
Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose
The primary objectives of this study are: 1. To obtain information on the pharmacokinetics of cytisinicline following a single oral dose in subjects with varying degrees of renal impairment relative to matched controls with…
- Trial name
- NCT05631938
- Testing
- cytisinicline
- Where
- 6 sites in Portugal, Spain
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Achieve Life Sciences
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