Clinical trials: Moderate Nephropathy
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
A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease
The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects
- Trial name
- NCT03913000
- Testing
- ID-085
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Renal Impairment
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.
- Trial name
- NCT01443429
- Testing
- beraprost sodium(BPS)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Toray Industries, Inc
Pharmacokinetics of MDV3100, Healthy Subjects
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects. The study will consist of two treatment arms.
- Conditions
- Pharmacokinetics of MDV3100, Healthy Subjects, Kidney Diseases
- Trial name
- NCT01901133
- Testing
- MDV3100
- Where
- Moldova
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Chronic Kidney Disease (CKD)
Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function
This was a randomized, double-blind, parallel group, placebo-controlled study, in two sequential parts that evaluated the renal safety, tolerability and pharmacokinetics of LHW090 in patients with moderately impaired renal…
- Trial name
- LHW090 (NCT02678000)
- Testing
- LHW090
- Where
- 12 sites in United States, Germany
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Kidney Disease
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
- Trial name
- NCT01444872
- Testing
- TRV120027, Normal Saline
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Trevena Inc.
Renal Impairment
A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants
The objective of this study is to measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.
- Trial name
- NCT05363215
- Testing
- S-217622
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shionogi
Chronic Hepatitis C Virus
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)
The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in…
- Trial name
- GIFT-R (NCT02806362)
- Testing
- Ombitasvir/paritaprevir/ritonavir
- Sponsor
- AbbVie
Hypertension, Diabetes Mellitus, Type 2
DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril
To compare the renal consequences of two different approaches to blocking the renin angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and diabetic nephropathy.
- Trial name
- NCT00274118
- Testing
- telmisartan, enalapril
- Where
- 37 sites in Denmark, Finland and 4 more
- Volunteers
- 250 people
- Sponsor
- Boehringer Ingelheim
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617)…
- Trial name
- NCT06004661
- Testing
- AAA617, 68Ga-PSMA-11
- Where
- 9 sites in United States, France and 3 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
- Trial name
- NCT00984113
- Testing
- Elinogrel
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Renal Impairment
Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
This study is being conducted to investigate the PK, safety, and tolerability of opemalirsen in participants with renal impairment, compared to participants with normal renal function.
- Trial name
- NCT07154901
- Testing
- Opemalirsen (AZD2373)
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Impairment
A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function
The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal…
- Trial name
- NCT05940402
- Testing
- Emraclidine
- Where
- 5 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- AbbVie
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
Renal Impairment, Disease Severity
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with…
- Trial name
- NCT02199379
- Testing
- Lenvatinib
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
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.
Renal Impairment
Safinamide Renal Impairment Trial
The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal…
- Trial name
- NCT01374113
- Testing
- 50mg safinamide
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA
Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate)
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease.
- Conditions
- Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe), Diabetes
- Trial name
- NCT03795389
- Testing
- DM199
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- DiaMedica Therapeutics Inc
Type 2 Diabetes Mellitus, Renal Impairment
Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate…
- Trial name
- NCT01555008
- Testing
- LX4211
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Lexicon Pharmaceuticals
Renal Insufficiency, Renal Impairment
Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg intravenous (IV) dose of sugammadex in participants with moderate and severe renal insufficiency compared to that in participants with…
- Trial name
- NCT02011490
- Testing
- sugammadex
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC