Clinical trials: Renal Insufficiency
Chronic Kidney Disease (CKD), Hyperkalemia (HK)
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium).
- Trial name
- OPAL (NCT01810939)
- Testing
- Patiromer
- Where
- 58 sites in United States, Croatia and 8 more
- Volunteers
- 243 people
- Sponsor
- Relypsa, Inc.
Renal Impairment
Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis
- Trial name
- NCT01464931
- Testing
- Denosumab
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Amgen
Atrial Fibrillation
Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment
Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment
- Trial name
- NCT01721837
- Where
- 1,616 sites in Germany
- Volunteers
- 4,340 people
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT03893799
- Testing
- RBT-1
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Anaemia
4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia…
- Trial name
- NCT01587898
- Testing
- GSK1278863
- Where
- 55 sites in United States, Canada and 1 more
- Volunteers
- 72 people
- Sponsor
- GlaxoSmithKline
Renal Insufficiency
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial.
- Trial name
- RESCUE (NCT00650845)
- Testing
- Dotarem®-enhanced MRI, non-enhanced MRI
- Where
- 15 sites in Belgium, France and 2 more
- Volunteers
- 135 people
- Sponsor
- Guerbet
Diabetes Mellitus, Type 2
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients…
- Trial name
- NCT01087502
- Testing
- Glimepiride, Linagliptin
- Where
- 52 sites in United States, Australia and 7 more
- Volunteers
- 241 people
- Sponsor
- Boehringer Ingelheim
Diabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia
DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.
- Trial name
- NCT02607280
- Testing
- DS-5565
- Where
- Japan
- Volunteers
- 35 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism
- Trial name
- NCT05543928
- Testing
- CTAP101
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OPKO Health, Inc.
Chronic Kidney Disease, Anemia
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.
- Trial name
- DIAMOND (NCT01478971)
- Testing
- Epoetin, Peginesatide
- Where
- 5 sites in United States
- Volunteers
- 184 people
- Sponsor
- Takeda
Secondary Hyperparathyroidism
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months.
- Trial name
- NCT01401478
- Where
- 13 sites in Russia
- Volunteers
- 86 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease
A Study of LY3113593 in Participants With Chronic Kidney Disease
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes…
- Trial name
- NCT02604160
- Testing
- LY3113593
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company
Chronic Renal Failure, Chronic Kidney Disease
Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA)…
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- PEARL 2 (NCT00598442)
- Testing
- peginesatide, Darbepoetin alfa
- Where
- 64 sites in United States, Bulgaria and 8 more
- Volunteers
- 493 people
- Sponsor
- Affymax
Anemia of End Stage Renal Disease
TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients
- Trial name
- NCT02378662
- Testing
- MDGN201 TARGTEPO
- Where
- 2 sites in Israel
- Volunteers
- 2 people
- Sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
Kidney Disease, Chronic
A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis
This study is open to adults with a type of kidney disease called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in…
- Trial name
- NCT05213624
- Testing
- BI 764198
- Where
- 54 sites in United States, Australia and 8 more
- Volunteers
- 67 people
- Sponsor
- Boehringer Ingelheim
End Stage Renal Disease
Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
The main purpose is to establish the equivalence of Triferic iron administered via dialysate into the arterial blood line and into the venous blood line
- Trial name
- NCT03303144
- Testing
- Triferic
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Chronic Kidney Disease, Anemia
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
- Trial name
- NCT01244763
- Testing
- Roxadustat
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Kyntra Bio
Secondary Hyperparathyroidism, End-Stage Renal Disease
Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT).
- Trial name
- NCT01134315
- Testing
- Paricalcitol, Calcitriol
- Where
- 18 sites in United States
- Volunteers
- 61 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Diabetes Mellitus, Type 2, Chronic Renal Insufficiency
An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)
The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).
- Trial name
- NCT00095056
- Testing
- sitagliptin, glipizide
- Volunteers
- 91 people
- Sponsor
- Merck Sharp & Dohme LLC
Fabry Disease, Chronic Kidney Disease, Stage IV (Severe)
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
- Trial name
- NCT00837824
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Genzyme, a Sanofi Company