Clinical trials: Kidney Dysfunction
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
Diabetes Mellitus and Heart Failure
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure
- Trial name
- NCT03152552
- Testing
- LIK066, Empagliflozin
- Where
- 106 sites in United States, Argentina and 22 more
- Volunteers
- 125 people
- Sponsor
- Novartis Pharmaceuticals
Renal Insufficiency
Afatinib in Subjects With Kidney Dysfunction
The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal…
- Trial name
- NCT02096718
- Testing
- Afatinib healthy, Afatinib severe renally impaired, Afatinib moderate renally impaired
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cognitive Impairment, End Stage Renal Disease
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
This study will evaluate the tolerability, feasibility, and efficacy of the AKST1210 column in subjects with end-stage renal disease with cognitive impairment (ESRD-CI) undergoing hemodialysis 3 times per week.
- Trial name
- NCT04527328
- Testing
- AKST1210, Hemodialysis
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Alkahest, Inc.
Acute-On-Chronic Liver Failure, Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and…
- Trial name
- NCT05900050
- Testing
- VS-01 on top of SOC, SOC (Control Group)
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Genfit
Chronic Kidney Diseases, Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD)…
- Trial name
- NCT03617536
- Testing
- CR845 0.25 mg Oral Tablet, CR845 0.5 mg Oral Tablet, CR845 1 mg Oral Tablet
- Where
- 60 sites in United States
- Volunteers
- 269 people
- Sponsor
- Cara Therapeutics, Inc.
Renal Impairment
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.
- Trial name
- NCT00999336
- Testing
- Betrixaban
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Type 2 Diabetes, Renal Impairment
A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction
The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532).
- Trial name
- NCT05510245
- Testing
- PF-07081532
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Pfizer
Heart Failure
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic…
- Trial name
- ARTS-HF (NCT01807221)
- Testing
- Finerenone (BAY94-8862), Inspra (eplerenone)
- Where
- 172 sites in United States, Australia and 23 more
- Volunteers
- 1,066 people
- Sponsor
- Bayer
Uremic Pruritus
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
- Trial name
- NCT03998163
- Testing
- CR845 0.5 mcg/kg
- Where
- 47 sites in United States, Czechia and 2 more
- Volunteers
- 222 people
- Sponsor
- Cara Therapeutics, Inc.
Renal Insufficiency
Assessing the Behavior of Met DR in Subjects With Kidney Dysfunction
This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction.
- Trial name
- NCT01658514
- Testing
- Met DR, Met XR
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Elcelyx Therapeutics, Inc.
Hypertension With Renal Dysfunction
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
- Trial name
- NCT01593787
- Testing
- LCZ696
- Where
- 13 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Uremic Pruritus
Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
- Trial name
- NCT03281538
- Testing
- CR845
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 288 people
- Sponsor
- Cara Therapeutics, Inc.
Hyperkalemia, Chronic Kidney Disease
Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia
It is hypothesized that zirconium silicate is safe and well tolerated and more effective than placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum potassium between 5 - 6.0 mmol/l versus no…
- Conditions
- Hyperkalemia, Chronic Kidney Disease, Kidney Dysfunction
- Trial name
- NCT01493024
- Testing
- Zirconium silicate (ZS)
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- ZS Pharma, Inc.
Allografts, Rejection; Transplant, Kidney
A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased…
- Conditions
- Allografts, Rejection; Transplant, Kidney, Transplant Rejection, Kidney Transplantation
- Trial name
- NCT04046549
- Testing
- Belatacept, VIB4920, Thymoglobulin
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Amgen
Uremic Pruritus
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- KALM-2 (NCT03636269)
- Testing
- CR845 0.5 mcg/kg
- Where
- 92 sites in United States, Australia and 9 more
- Volunteers
- 473 people
- Sponsor
- Cara Therapeutics, Inc.