Clinical trials: Kidney Functional
PK in Patients With Various Degrees of Renal Impairment
Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects
This is a Phase 1, multi-center, open-label, PK and safety study of a single dose of AAI101 in combination with cefepime in male and female subjects with mild renal impairment (Group 1, n = 6), moderate renal impairment (Group 2…
- Trial name
- NCT03680352
- Testing
- cefepime/AAI101
- Where
- 2 sites in Czechia, Hungary
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Allecra
Diabetes
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.
- Trial name
- NCT06547502
- Testing
- GZR4
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Fabry Disease
Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function
This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects with normal renal function and to subjects…
- Trial name
- NCT01730469
- Testing
- AT1001 150 mg
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amicus Therapeutics
Moderate Renal Impairment
Clofutriben Pharmacokinetics in Patients With Impaired Renal Function
This is a Phase 1, single-center, open-label, single-dose trial. Sixteen participants are planned: 8 participants with moderate renal impairment and 8 matched control participants with normal renal function.
- Trial name
- RENAL (NCT07227922)
- Testing
- 12mg clofutriben
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sparrow Pharmaceuticals
Heart Failure, Congestive
PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added to IV loop diuretics in…
- Trial name
- NCT00354458
- Testing
- rolofylline
- Volunteers
- 1,102 people
- Sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Renal Impairment
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe…
- Trial name
- NCT06397872
- Testing
- 100 mg Resmetirom Tablet
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2, Plasma Volume
A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus
The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.
- Trial name
- NCT01483781
- Testing
- Canagliflozin
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- Janssen Research & Development, LLC
Renal Impairment, Hemodialysis
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.
- Trial name
- NCT05099445
- Testing
- INCB000928
- Where
- 5 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Healthy Volunteers, Patients
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.
- Conditions
- Healthy Volunteers, Patients, Pharmacokinetics, Renal Impairment
- Trial name
- NCT01240967
- Testing
- TC-5214
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Obesity & Overweight
A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients
This Phase 1 study is designed to evaluate the pharmacokinetics and safety of a single oral dose of VCT220 (other name: CX11) in subjects with moderate renal impairment compared with age-, sex-, and body mass index (BMI)-matched…
- Trial name
- NCT07347808
- Testing
- VCT220
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vincentage Pharma Co., Ltd
Cardiovascular Disease
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment…
- Trial name
- NCT01825889
- Testing
- Evacetrapib
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Renal Impairment
Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function
Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD)…
- Trial name
- NCT04178577
- Testing
- Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics
Long QT Syndrome
Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired renal function.
- Trial name
- NCT02441829
- Testing
- Eleclazine
- Where
- 7 sites in United States, Moldova and 1 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Infectious Disease
A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)
This is a 2-part study of the pharmacokinetics (PK) of MK-7655. In Part I, the PK of a single 125 mg dose of MK-7655 given in combination with 250 mg of PRIMAXIN® (imipenem + cilastatin) will be determined in participants with…
- Trial name
- NCT01275170
- Testing
- MK-7655, Imipenem + Cilastatin, Caffeine
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Artery Bypass Surgery, Coronary Heart Disease
An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)
The purpose of this study is to assess whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) patients undergoing heart bypass graft surgery that…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00530361
- Testing
- Nesiritide
- Sponsor
- Scios, Inc.
Preeclampsia, Hypertension
Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S.
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia
- Trial name
- NCT02780414
- Where
- 20 sites in United States
- Volunteers
- 1,730 people
- Sponsor
- Progenity, Inc.
Chronic Kidney Disease, Acute Kidney Injury
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with acute kidney injury (AKI).
- Trial name
- NCT01978314
- Testing
- 75 mg / 6 mL VFI™
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- FAST BioMedical
Human Immunodeficiency Virus (HIV) Infection
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.
- Trial name
- NCT00717067
- Testing
- Maraviroc, Ritonavir, Saquinavir
- Where
- 2 sites in Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Chronic Kidney Disease, Hepatic Impairment
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time.
- Trial name
- NCT06402721
- Testing
- BAY3283142
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Diabetes Mellitus, Type 2
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.
- Trial name
- NCT01478399
- Testing
- PB1023 Injection
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PhaseBio Pharmaceuticals Inc.