Clinical trials: Haemodialysis
Renal Failure Chronic Requiring Hemodialysis
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD)…
- Trial name
- CRUISE 1 (NCT01320202)
- Testing
- Soluble Ferric Pyrophosphate (SFP), Standard dialysate
- Where
- 47 sites in United States, Puerto Rico
- Volunteers
- 305 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Hemodialysis, Ultrafiltration, Bioimpedance
Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes
Patient submitted to hemodialysis are followed through a dialysis - interim - dialysis cycle. No intervention is done. Additional blood tests and clinical tests are used as pseudo-endpoints.
- Trial name
- CTR006 (NCT04937478)
- Testing
- Observation
- Where
- 2 sites in Norway
- Volunteers
- 31 people
- Sponsor
- Mode Sensors AS
Chronic Kidney Disease, End Stage Renal Disease
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the…
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification
- Trial name
- NCT00379899
- Testing
- cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
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
Hyperphosphatemia
DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis
This three-part study will be performed with participants on chronic hemodialysis. Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations…
- Trial name
- NCT03305471
- Testing
- DS-2330b PIB, Sevelamer, DS-2330b Tablet
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Daiichi Sankyo
Anaemia
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in…
- Trial name
- NCT01977482
- Testing
- GSK1278863, rhEPO
- Where
- 107 sites in United States, Australia and 14 more
- Volunteers
- 216 people
- Sponsor
- GlaxoSmithKline
ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia
The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.
- Trial name
- NCT02780141
- Testing
- roxadustat
- Where
- 47 sites in Japan
- Volunteers
- 75 people
- Sponsor
- Astellas Pharma Inc
End Stage Renal Disease
Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.
- Trial name
- NCT01340586
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Anemia Associated With Chronic Kidney Disease
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease
This study will be conducted to assess the pharmacokinetics of vadadustat 600, 750, and 900 milligrams daily, and intravenous erythropoiesis-stimulating agent (darbepoetin alfa or epoetin alfa), in hemodialysis participants with…
- Trial name
- NCT03992066
- Testing
- Vadadustat, Darbepoetin alfa, Epoetin alfa
- Where
- 10 sites in United States
- Volunteers
- 46 people
- Sponsor
- Akebia Therapeutics
Malnutrition, Complication of Hemodialysis
Intradialytic Parenteral Nutrition in Hemodialysis Patients
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.
- Trial name
- IDPNHD (NCT00501956)
- Testing
- Intradialytic Parenteral Nutrition (IDPN)
- Where
- Germany
- Volunteers
- 140 people
- Sponsor
- Fresenius Kabi
Renal Insufficiency, Chronic
To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects
The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and…
- Trial name
- NCT02312973
- Testing
- Molidustat(BAY85-3934)
- Where
- 2 sites in Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bayer
Anemia
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia.
- Trial name
- NCT00661505
- Testing
- methoxy polyethylene glycol-epoetin beta
- Where
- 20 sites in Turkey (Türkiye)
- Volunteers
- 132 people
- Sponsor
- Hoffmann-La Roche
End-Stage Renal Disease
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
- Trial name
- NCT05880537
- Testing
- Nexeon Arterial Venous Allograft
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- LifeNet Health
Hemodialysis Complication
Oral Nutritional Supplementation of Hemodialysis Patients
This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment…
- Trial name
- NCT05333692
- Testing
- Fresubin® Protein Energy DRINK, NEPRO® , Abbott
- Where
- Taiwan
- Volunteers
- 90 people
- Sponsor
- Fresenius Kabi Taiwan Ltd.
End Stage Renal Disease on Hemodialysis (Diagnosis)
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
- Trial name
- NCT03934736
- Testing
- HEPLISAV-B®
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Kidney Disease
Dialysis Clinical Outcomes Revisited (DCOR) Trial
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients.
- Trial name
- NCT00324571
- Testing
- Sevelamer hydrochloride, Calcium-based phosphate binder
- Where
- 73 sites in United States, Puerto Rico
- Volunteers
- 2,000 people
- Sponsor
- Genzyme, a Sanofi Company
Epilepsy
Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite
This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8 patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis.
- Trial name
- NCT01480609
- Testing
- Retigabine / Ezogabine
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- GlaxoSmithKline
Renal Failure Chronic Requiring Hemodialysis
Performance Comparison of Revaclear With Larger Dialyzer
The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area.
- Trial name
- Revacom HD (NCT01722695)
- Testing
- Dialyzer comparison
- Where
- 2 sites in Austria
- Volunteers
- 30 people
- Sponsor
- Vantive Health LLC
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
Chronic Kidney Disease, Chronic Renal Failure
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated…
- Trial name
- AiME - 01 (NCT01473407)
- Testing
- Epoetin Hospira, Epogen (Amgen)
- Where
- 85 sites in United States, Puerto Rico
- Volunteers
- 612 people
- Sponsor
- Pfizer