Clinical trials: Kidney Functional
Renal Impairment
Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of asciminib following a single oral dose in adult subjects with renal impairment compared to a matched group of healthy subjects with…
- Trial name
- NCT03605277
- Testing
- Asciminib
- Where
- 2 sites in Bulgaria, Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
- Trial name
- NCT03443063
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai 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
Renal Function
Study to Develop a Tool to Estimate the Kidney Function in Databases Without Laboratory Data
Scientific analyses are frequently performed on e.g. health insurance databases to study the usage and effectiveness of drugs in real life.
- Trial name
- NCT03605810
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 5,132,200 people
- Sponsor
- Bayer
Advanced Solid Tumors, Kidney Disease
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of renal dysfunction) will receive weekly doses of…
- Conditions
- Advanced Solid Tumors, Kidney Disease, Renal Impairment
- Trial name
- NCT01331941
- Testing
- AMG 386 + Paclitaxel, AMG 386
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Amgen
Renal Impairment
Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal…
- Trial name
- NCT07857837
- Testing
- Sulthiame
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy, Renal Insufficiency
A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function
The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy…
- Trial name
- NCT05469100
- Testing
- Selpercatinib
- Where
- 6 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetes, Diabetes Mellitus, Type 2
Effect of Renal Impairment on the Pharmacokinetics of NN9535
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Renal Impairment
- Trial name
- NCT00833716
- Testing
- semaglutide
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Delayed Graft Function, Other Complications of Kidney Transplant
Biomarkers of Aging as Predictors of Kidney Transplant Function
The primary purpose of this study is to measure the correlation between baseline expression of aging biomarkers, SenesceTest in blood of organ donor and renal graft function.
- Trial name
- NCT02335333
- Testing
- No treatment
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sapere Bio
Renal Impairment
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild…
- Trial name
- NCT03159416
- Testing
- Inclisiran
- Where
- 2 sites in New Zealand
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- The Medicines Company
Heart Transplantation
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant.
- Trial name
- NCT02091414
- Testing
- mycophenolate mofetil (MMF), cyclosporine A (CsA), corticosteroids
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
Renal Impairment, Healthy Volunteers
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75…
- Trial name
- NCT07853131
- Testing
- rilzabrutinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Renal Insufficiency
Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients
The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid…
- Trial name
- NCT01957657
- Testing
- BI 207127, faldaprevir
- Where
- Germany
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Multiple Myeloma
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form…
- Trial name
- NCT02921828
- Where
- 2 sites in United States, Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Type 2 Diabetes Mellitus
Renal Impairment Study With ASP1941
A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy…
- Trial name
- NCT01302028
- Testing
- ASP1941
- Where
- 5 sites in Czechia, Hungary and 2 more
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Normal Renal Function, Mildly Impaired Renal Function
Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).
- Conditions
- Normal Renal Function, Mildly Impaired Renal Function, Moderately Impaired Renal Function
- Trial name
- NCT00543075
- Testing
- Genasense (oblimersen, G3139)
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Genta Incorporated
Renal Impairments, IgA Nephropathy (IgAN)
A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous…
- Trial name
- NCT07445906
- Testing
- RG002C0106
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
Liver Transplantation
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants.
- Trial name
- NCT00717314
- Testing
- Mycophenolate mofetil, CNI (50%), CNI (≥75%)
- Where
- 11 sites in China
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
Hypertension, Hyperhomocysteinemia
CSPPT- Chronic Kidney Diseases Study
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing renal function decline among the patients with primary hypertension when compared to enalapril maleate.
- Trial name
- CSPPT-CKD (NCT01871740)
- Testing
- Enalapril maleate and folic acid tablets, Enalapril maleate
- Where
- 2 sites in China
- Sponsor
- Shenzhen Ausa Pharmed Co.,Ltd
Diabetes Mellitus, Type 2, Liver Diseases
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath.
- Conditions
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases, Lung Diseases
- Trial name
- RESPYR-SBA (NCT07646015)
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Respyr