Clinical trials: Renal Dysfunction
Acute Heart Failure
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared…
- Trial name
- NCT02002702
- Testing
- Serelaxin
- Where
- 15 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Nephrology
A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)
Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters
- Trial name
- NCT00189501
- Testing
- Sensipar®
- Volunteers
- 1,000 people
- Sponsor
- Amgen
End Stage Renal Disease, Renal Impairment
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD)…
- Trial name
- NCT04994522
- Testing
- Belzutifan
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Observational Prospective Study on Patients Treated With Norditropin®
This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Adult Growth Hormone Deficiency, Genetic Disorder
- Trial name
- NCT00960128
- Testing
- somatropin
- Where
- 23 sites in Argentina, Belgium and 21 more
- Volunteers
- 21,249 people
- Sponsor
- Novo Nordisk A/S
Multiple Myeloma
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have…
- Trial name
- NCT02922543
- Where
- Japan
- Volunteers
- 361 people
- Sponsor
- Celgene
Kidney Failure, Chronic, Healthy Volunteers
A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis
The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278.
- Conditions
- Kidney Failure, Chronic, Healthy Volunteers, Renal Impairment
- Trial name
- NCT06723535
- Testing
- BMS-986278
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Anaemia
Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment
This will be an open-label, parallel-group study to evaluate the pharmacokinetics of GSK1278863 and metabolites in normal subjects and subjects with impaired renal function, including those who are hemodialysis dependent.
- Trial name
- NCT01406340
- Testing
- 5 mg GSK1278863
- Where
- 3 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
End-stage Renal Disease
Xeltis Hemodialysis Access Graft: aXess Pivotal Study
A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis…
- Trial name
- NCT05473299
- Testing
- Xeltis Hemodialysis Access (aXess) graft
- Where
- 22 sites in Belgium, Germany and 7 more
- Volunteers
- 120 people
- Sponsor
- Xeltis
Glomerular Disease, Proteinuria
Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease
The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.
- Trial name
- NCT04939116
- Testing
- ANG-3070
- Where
- 30 sites in United States, Australia and 1 more
- Volunteers
- 100 people
- Sponsor
- Angion Biomedica Corp
Renal Impairment
Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment
The purpose of this study is to evaluate the PK properties of lorcaserin in subjects with end stage renal disease (ESRD) who require dialysis and will be studied under dialysis and non-dialysis conditions.
- Trial name
- NCT00828438
- Testing
- Lorcaserin 10mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eisai 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.
Anemia of End Stage Renal Disease
TARGTEPO Treatment for Anemia in PD US Trial
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients
- Trial name
- NCT02468414
- Testing
- MDGN201 TARGTEPO
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
Chronic Kidney Disease, Dialysis
Dose-finding Study of MCI-196
The Primary Objective of this study is to determine the initial starting doses of colestilan (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with Hyperphosphataemia.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric
- Trial name
- NCT01814904
- Testing
- colestilan-L, colestilan-M, colestilan-H
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Diseases, Hemodialysis
Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention
The aims of this study are to: Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder).
- Conditions
- Chronic Kidney Diseases, Hemodialysis, Vascular Access Complication, Hemodialysis Access Failure
- Trial name
- MuST (NCT05081648)
- Testing
- CT MuST, Rope-ladder cannulation technique
- Where
- 3 sites in Portugal
- Volunteers
- 101 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Chronic Kidney Disease
Phase 1a Study Assessing Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PMG1016
This study is a first-in-human (FIH), randomized, double-blind, placebo-controlled study of PMG1016 in healthy adult participants.
- Trial name
- NCT07615985
- Testing
- PMG1016 Dose 1, PMG1016 Dose 2, PMG1016 Dose 3
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pulmongene Ltd.
Hemodialysis
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in…
- Trial name
- NCT05533008
- Testing
- CR845 0.5 mcg/kg
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Cara Therapeutics, Inc.
Renal Failure, Chronic Kidney Diseases
Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients
The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy.
- Trial name
- pPD (NCT06443021)
- Testing
- PD cycler
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Cardiac Surgery, Coronary Artery Bypass Grafting
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Aortic Root or Ascending Aortic Aneurysm Repair Surgery
- Trial name
- NCT00903604
- Testing
- AP214
- Where
- 2 sites in Denmark
- Volunteers
- 42 people
- Sponsor
- Action Pharma A/S
Anaemia
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated…
- Trial name
- ASCEND-P (NCT05682326)
- Testing
- Daprodustat
- Where
- 4 sites in Japan, South Korea
- Volunteers
- 4 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
Outcome of Use of a Novel Modulator of Oxidative Phosphorylation on Kidney Function in Patients With Progressive Chronic Kidney Disease
Outcome of use of a novel Modulator of Oxidative Phosphorylation on kidney function in patients with Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5), Proteinuria
- Trial name
- NCT07150338
- Testing
- QRX-3, Eseronate
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Neukidney Inc.
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