Clinical trials: Chronic Nephropathy
Anaemia
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)
The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.
- Trial name
- NCT03409107
- Testing
- Daprodustat (GSK1278863), Iron therapy
- Where
- 168 sites in United States, Argentina and 12 more
- Volunteers
- 614 people
- Sponsor
- GlaxoSmithKline
End Stage Renal Disease
An Effectiveness-Implementation Trial of SPIRIT in ESRD
Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset of end-stage renal disease (ESRD).
- Trial name
- NCT03138564
- Testing
- SPIRIT, Comparison Condition
- Where
- 39 sites in United States
- Volunteers
- 852 people
- Sponsor
- Emory University
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
Hyperphosphatemia, End-Stage Renal Disease
A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs.
- Trial name
- NCT01074125
- Testing
- ferric citrate
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 154 people
- Sponsor
- Keryx Biopharmaceuticals
End-Stage Renal Disease, End-Stage Kidney Disease
Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)
The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an…
- Conditions
- End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic
- Trial name
- NCT05027074
- Testing
- MK-2060
- Where
- 120 sites in United States, Argentina and 13 more
- Volunteers
- 506 people
- Sponsor
- Merck Sharp & Dohme LLC
End-stage Renal Disease
Vitamin D and Arteriovenous Fistulae
Patients requiring hemodialysis following kidney failure need a form of dialysis vascular access in order to undergo the dialysis procedure. Dialysis vascular access dysfunction is an enormous clinical problem.
- Trial name
- NCT00912782
- Testing
- Vitamin D3
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Emory University
Renal Failure, End Stage Renal Disease
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Trial name
- NCT04135417
- Testing
- HAV
- Where
- 2 sites in Poland
- Volunteers
- 30 people
- Sponsor
- Humacyte, Inc.
End Stage Renal Disease
Potential Effect of Dialyzer Leaching of BPA From the Fresenius Optiflux 160NR Compared to the Nipro ELISIO-15H
The aim of the study is to identify hepatic enzyme and estrogen-dependent biochemical changes that occur when dialysis patients are treated with dialyzers known to leach BPA (Bisphenol-A) into the blood, such as the commercially…
- Trial name
- bisphenol-A (NCT02627118)
- Testing
- FRESENIUS 160NR, NIPRO ELISIO-15H
- Volunteers
- 10 people
- Sponsor
- UConn Health
CKD Anemia
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
- Trial name
- NCT01750190
- Testing
- Roxadustat
- Where
- 145 sites in United States, Argentina and 14 more
- Volunteers
- 922 people
- Sponsor
- Kyntra Bio
Chronic Kidney Disease on Hemodialysis, Secondary Hyperparathyroidism
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
- Trial name
- NCT00667576
- Testing
- Maxacalcitol, Paricalcitol
- Where
- 12 sites in Japan
- Volunteers
- 153 people
- Sponsor
- Abbott
Chronic Kidney Diseases
Kidney Coordinated Health Management Partnership
As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a multifaceted Electronic Health Record…
- Trial name
- Kidney-CHAMP (NCT03832595)
- Testing
- EHR-based PHM, Usual Care
- Where
- United States
- Volunteers
- 1,596 people
- Sponsor
- University of Pittsburgh
End Stage Renal Disease, Vascular Access Patency
Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited.
- Trial name
- NCT02335099
- Testing
- ticagrelor
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Virginia
Chronic Kidney Disease, Metabolic Acidosis
Bicarbonate Administration in CKD
Low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death.
- Trial name
- NCT02915601
- Testing
- Sodium bicarbonate
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- University of Colorado, Denver
Chronic Renal Failure, Chronic Kidney Disease
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- EMERALD 2 (NCT00597584)
- Testing
- peginesatide, Epoetin alfa or Epoetin beta
- Where
- 84 sites in United States, Bulgaria and 7 more
- Volunteers
- 823 people
- Sponsor
- Affymax
End Stage Renal Disease
SPIRIT for Persons With Dementia and Complex Multimorbidity
In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on…
- Trial name
- NCT04108000
- Testing
- SPIRIT-Dementia, Usual Care
- Where
- 4 sites in United States
- Volunteers
- 38 people
- Sponsor
- Emory University
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Anemia, Chronic Kidney Disease (CKD)
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously.
- Trial name
- ACCESS (NCT01693029)
- Testing
- HX575 epoetin alfa, US-licensed epoetin alfa
- Where
- 52 sites in United States
- Volunteers
- 435 people
- Sponsor
- Sandoz
End Stage Renal Disease
Acid-Base Composition With Use of hemoDialysates
This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid…
- Trial name
- ABChD (NCT02334267)
- Testing
- Group 1: GranuFlo, Group 2: NaturaLyte
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Fresenius Medical Care North America
Anemia, Dialysis-Dependent Chronic Kidney Disease
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis…
- Trial name
- NCT03140722
- Testing
- vadadustat, epoetin alfa
- Where
- 18 sites in United States
- Volunteers
- 2 people
- Sponsor
- Akebia Therapeutics
Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole…
- Trial name
- NCT02054572
- Testing
- [¹⁴C]Etelcalcetide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Amgen