Clinical trials: Complication of Renal Dialysis
Chronic Hemodialysis (ESRD)
Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD
This study is a pilot study designed to compare the safety and cardiovascular effects of 26 weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in patients receiving chronic hemodialysis.
- Trial name
- HIDE (NCT02228408)
- Testing
- Hydralazine/Isorsorbide Dinitrate
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Brigham and Women's Hospital
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
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
End-stage Renal Disease
Propaten Randomized Investigation on Cost-benefit and Efficacy
The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.
- Trial name
- PRICE (NCT01601873)
- Testing
- PROPATEN, Standard Graft
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- The University of Texas Health Science Center, Houston
Kidney Failure, End Stage Renal Disease
Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)
The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD).
- Conditions
- Kidney Failure, End Stage Renal Disease, Hypotension, Cardiovascular Diseases
- Trial name
- Dialysafe (NCT03171545)
- Testing
- Patient Activation, Provider Education
- Where
- United States
- Volunteers
- 1,431 people
- Sponsor
- University of Michigan
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
End-Stage Renal Disease
Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.
- Trial name
- SPin-D (NCT02285920)
- Testing
- Spironolactone
- Where
- 4 sites in United States
- Volunteers
- 129 people
- Sponsor
- University of Pennsylvania
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
End-stage Renal Disease
Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration
An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid…
- Trial name
- NCT01923961
- Testing
- HDF NaCl, Hemodialysis, Standard Predilution Hemodiafiltration
- Where
- Germany
- Volunteers
- 8 people
- Sponsor
- EXcorLab GmbH
Acute Kidney Injury, Fluid Overload
Restrictive Versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury
Critically ill patients with acute kidney injury and fluid overload who are frequently treated by fluid removal during dialysis are at an increased risk of complications and death.
- Conditions
- Acute Kidney Injury, Fluid Overload, Hypotension, Dialysis; Complications
- Trial name
- RELIEVE-AKI (NCT05306964)
- Testing
- Restrictive UFnet Rate Strategy, Liberal UFnet Rate Strategy
- Where
- 2 sites in United States
- Volunteers
- 99 people
- Sponsor
- University of Pittsburgh
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
End Stage Renal Disease
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).
- Trial name
- Xigris1003 (NCT01227187)
- Testing
- Drotrecogin alfa activated (Xigris)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- George Washington University
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)
Hemodialysis Complication, Hypotension of Hemodialysis
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced…
- Trial name
- Hinder (NCT05297786)
- Testing
- Lanadelumab Injection [Takhzyro]
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Vanderbilt University Medical Center
Chronic Kidney Disease
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
- Trial name
- SENSE (NCT01576341)
- Testing
- HX575 epoetin alfa (Sandoz)
- Where
- 50 sites in Germany, Italy and 5 more
- Volunteers
- 417 people
- Sponsor
- Sandoz
End-Stage Renal Disease
Anti-Cytokine Therapy for Hemodialysis InflammatION
Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis.
- Trial name
- ACTION (NCT03141983)
- Testing
- Anakinra
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of Pennsylvania
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
- Trial name
- NCT01439867
- Testing
- Cinacalcet hydrochloride, Standard of Care
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 18 people
- Sponsor
- Amgen
Anemia
A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
- Trial name
- NCT01146574
- Testing
- Sotatercept
- Where
- 24 sites in United States
- Volunteers
- 50 people
- Sponsor
- Celgene