Clinical trials: End-stage Renal Failure
End-stage Renal Disease (ESRD)
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.
- Trial name
- NCT02553889
- Testing
- ISIS 416858
- Where
- 8 sites in Canada
- Volunteers
- 49 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
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
End Stage Kidney Disease, End Stage Renal Disease
Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study
Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.
- Conditions
- End Stage Kidney Disease, End Stage Renal Disease, Acute Kidney Injury
- Trial name
- COMPARE (NCT04912024)
- Testing
- Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System, Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems
- Where
- 2 sites in United States
- Volunteers
- 458 people
- Sponsor
- Outset Medical
End Stage Renal Disease
Home With TablO outcoMEs (HOME) Registry
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.
- Trial name
- HOME (NCT04526301)
- Testing
- Tablo Hemodialysis System
- Where
- 10 sites in United States
- Volunteers
- 500 people
- Sponsor
- Outset Medical
Hyperphosphatemia, Inflammation
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.
- Conditions
- Hyperphosphatemia, Inflammation, Renal Disease
- Trial name
- NCT00834301
- Testing
- Oral Multivitamin
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Nephrian
End-Stage Renal Disease, Secondary Hyperparathyroidism
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated…
- Trial name
- NCT01382212
- Testing
- paricalcitol
- Volunteers
- 13 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Secondary Hyperparathyroidism, End-stage Kidney Disease (ESKD)
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-1 (NCT05832931)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 362 people
- Sponsor
- Pathalys Pharma
Renally Impaired Subjects
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1…
- Trial name
- NCT02313103
- Testing
- lofexidine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Chronic Renal Failure With Hemodialysis
Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic…
- Trial name
- NCT03950687
- Testing
- Recombinant Human Erythropoiesis Injection (CHO cell), Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
End-Stage Renal Disease
L-Carnitine in Peritoneal Dialysis
The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy.
- Trial name
- NCT00922701
- Testing
- L-carnitine
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Iperboreal Pharma Srl
End Stage Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
Type 2 Diabetes Mellitus
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
- Trial name
- NCT04285983
- Testing
- Trelagliptin
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Takeda
Chronic Renal Failure
Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug
Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased.
- Trial name
- NCT02378194
- Testing
- HD-003 (800mg/day), HD-003 (1600mg/day)
- Volunteers
- 62 people
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Anemia
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis
The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.
- Trial name
- NCT01737879
- Testing
- Peginesatide, Epoetin alfa
- Where
- 23 sites in United States
- Volunteers
- 41 people
- Sponsor
- Amgen
End Stage Renal Disease (ESRD), End Stage Renal Disease on Dialysis
EXtension of Tablo TrEatmeNt Duration Registry
Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement…
- Conditions
- End Stage Renal Disease (ESRD), End Stage Renal Disease on Dialysis, Acute Kidney Injury
- Trial name
- XTEND (NCT04912050)
- Testing
- Tablo Hemodialysis System
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Outset Medical
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
Renal Failure, End Stage Renal Disease
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone…
- Trial name
- eMPORA (NCT03315624)
- Testing
- Dialyzer
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End Stage Renal Disease (ESRD), Diabetes
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients…
- Conditions
- End Stage Renal Disease (ESRD), Diabetes, CAPD
- Trial name
- EDEN (NCT01219959)
- Testing
- Dianeal, Dianeal, Extraneal, Nutrineal
- Where
- 16 sites in Colombia
- Volunteers
- 71 people
- Sponsor
- Vantive Health LLC
Anemia in Incident Dialysis Patients
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
- Trial name
- Himalayas (NCT02052310)
- Testing
- Roxadustat, Epoetin Alfa
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 1,043 people
- Sponsor
- Kyntra Bio