Clinical trials: Renal Function Abnormal
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
Renal Insufficiency, Healthy
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects
- Trial name
- NCT04024332
- Testing
- ACT-541468
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Delayed Graft Function
Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor…
- Trial name
- NCT02474667
- Testing
- ANG-3777
- Where
- 30 sites in United States
- Volunteers
- 253 people
- Sponsor
- Angion Biomedica Corp
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.
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.
Chronic Kidney Diseases, Pruritus
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced 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 oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in…
- Trial name
- NCT05342623
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 83 sites in United States
- Volunteers
- 286 people
- Sponsor
- Cara Therapeutics, Inc.
Healthy
Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction
A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy…
- Trial name
- NCT06383897
- Testing
- HS-10398
- Where
- China
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Uremic Pruritus
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients…
- Trial name
- NCT05031546
- Testing
- Difelikefalin
- Sponsor
- Cara Therapeutics, Inc.
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
Kidney Dysfunction
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to severe renal function impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated)…
- Trial name
- NCT02840812
- Testing
- Nemonoxacin
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Zhejiang Medicine Co., Ltd.
Healthy, Renal Dysfunction
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan…
- Trial name
- NCT04935294
- Testing
- Danicopan
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
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.
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.
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.
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.
Kidney Diseases, Kidney Disease, Chronic
Clinical Impact of the IBox As an Early Intervention TooL
International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.
- Conditions
- Kidney Diseases, Kidney Disease, Chronic, Kidney Transplant Rejection, Kidney Transplant; Complications
- Trial name
- NCT05112315
- Testing
- Predigraft
- Where
- 16 sites in Austria, France and 4 more
- Volunteers
- 507 people
- Sponsor
- Predict4Health
Gastrointestinal Cancer
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal dysfunction) based on their baseline measured…
- Trial name
- FOLFOX4 (NCT00094965)
- Testing
- Oxaliplatin (SR96669)
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Sanofi
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
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.
Chronic Kidney Diseases, Pruritus
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced 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 oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in…
- Trial name
- NCT05356403
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 75 sites in United States, Argentina and 11 more
- Volunteers
- 105 people
- Sponsor
- Cara Therapeutics, Inc.