Clinical trials: Kidney Insufficiency
Normal Renal Function, Impaired Renal Function
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal…
- Trial name
- NCT02431481
- Testing
- LEE011
- Where
- 4 sites in United States, Bulgaria and 2 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of…
- Trial name
- NCT05282030
- Testing
- tolebrutinib
- Where
- 4 sites in United States, Germany
- Volunteers
- 22 people
- Sponsor
- Sanofi
End Stage Renal Disease
Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal…
- Trial name
- ELIXIR (NCT03994471)
- Testing
- XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght, 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
- Where
- 41 sites in Denmark, Germany and 4 more
- Volunteers
- 170 people
- Sponsor
- Iperboreal Pharma Srl
Renal Impairment, Diabetes
Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
- Trial name
- NCT00818571
- Testing
- Vildagliptin
- Where
- Russia
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease
Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based…
- Trial name
- NCT01130831
- Testing
- Lanthanum carbonate
- Where
- 31 sites in Germany
- Volunteers
- 66 people
- Sponsor
- Shire
Chronic Kidney Failure, Secondary Hyperparathyroidism
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product…
- Trial name
- NCT01081665
- Where
- 19 sites in Greece
- Volunteers
- 237 people
- Sponsor
- Abbott
End Stage Renal Disease, AV Fistula
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Trial name
- NCT02363972
- Testing
- Ellipsys Vascular Access Catheter
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- Medtronic Endovascular
Heart Failure, Congestive
A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure
The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of Natrecor® (a recombinant form of the natural human peptide normally secreted by the heart in…
- Trial name
- NCT00270400
- Testing
- nesiritide
- Volunteers
- 255 people
- Sponsor
- Scios, Inc.
Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH)
A Single-Dose Pharmacokinetic Study of HRS-4729 Injection in Healthy Participants and Patients With Renal Impairment
This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8…
- Conditions
- Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH), Type 2 Diabetes Mellitus
- Trial name
- NCT07807059
- Testing
- HRS-4729
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis
To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM)…
- Trial name
- NCT02015780
- Testing
- Fasiglifam, Antihyperglycemic therapy
- Where
- 30 sites in United States, Bulgaria and 5 more
- Sponsor
- Takeda
Uterine Fibroids, Endometriosis
Pharmacokinetics and Safety of Vilaprisan in Renal Impairment
The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.
- Trial name
- NCT03411980
- Testing
- Vilaprisan (BAY1002670)
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Heart Failure; With Decompensation, Cardiorenal Syndrome
The Aortix CRS Pilot Study
The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome
- Conditions
- Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure
- Trial name
- NCT04145635
- Testing
- Aortix System
- Where
- 19 sites in United States, Australia
- Volunteers
- 21 people
- Sponsor
- Procyrion
Renal Impairment
Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with renal impairment compared to subjects with…
- Trial name
- NCT05515458
- Testing
- Chiglitazar
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Renal Insufficiency, Kidney Diseases
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis
This is a multi-center, open-label, parallel-group study to evaluate oral doses of INCB054707 in participants with varying levels of renal function or impairment.
- Trial name
- NCT05624723
- Testing
- INCB054707
- Where
- 2 sites in United States, Germany
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Chronic Kidney Disease, Arterial Hypertension
A Study to Learn About the Safety of BAY3283142 in People With Mild to Moderate High Blood Pressure
In this study, researchers want to learn about the safety of BAY3283142 after a single dose and multiple doses in participants with mild to moderate high blood pressure.
- Trial name
- NCT06428825
- Testing
- BAY3283142
- Where
- 2 sites in Germany
- Volunteers
- 75 people
- Sponsor
- Bayer
Renal Impairment
A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function.
- Trial name
- NCT02709382
- Testing
- Cefepime and Tazobactam combination
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NCT01327924
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 77 people
- Sponsor
- Novo Nordisk A/S
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package…
- Trial name
- NCT00584779
- Testing
- Gabapentin
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Anemia, Iron Deficiencies
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly.
- Conditions
- Anemia, Iron Deficiencies, Chronic Kidney Disease
- Trial name
- NCT07577817
- Testing
- CTX001 With and Without Iron, CTX001 With Iron, CTX001 Multiple Dose
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Cajal Therapeutics Inc.
Anemia, Chronic Kidney Disease
Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had…
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Trial name
- NCT00228436
- Testing
- peginesatide
- Where
- 13 sites in Poland, United Kingdom
- Volunteers
- 139 people
- Sponsor
- Affymax
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