Clinical trials: Haemodialysis
Malnutrition, ESRD
ProStat Supplementation in Dialysis Patients
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition.
- Trial name
- NCT00435123
- Testing
- Nutritional Supplement ProStat 64 twice a day
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care North America
Chronic Kidney Failure, Vascular Graft Occlusion
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid…
- Trial name
- NCT00074620
- Testing
- PEG-hirudin
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Speedel Pharma Ltd.
End-Stage Renal Disease Requiring Haemodialysis
Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation.
- Trial name
- Amplifi FIH (NCT07058610)
- Testing
- Amplifi Vein Dilation System
- Where
- Paraguay
- Volunteers
- 19 people
- Sponsor
- Amplifi Vascular, Inc.
Calciphylaxis
SEAPORT 1: Study of INZ-701 in Adults With Hemodialysis-Dependent End-Stage Kidney Disease
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic…
- Trial name
- SEAPORT 1 (NCT06283589)
- Testing
- INZ-701
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Inozyme Pharma
Chronic Renal Failure, Chronic Kidney Disease
A Phase 3 Study Comparing the Effects of Subcutaneous 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 subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients…
- Trial name
- AiME - 13 (NCT01473420)
- Testing
- Epoetin Hospira, Epogen Amgen
- Where
- 73 sites in United States
- Volunteers
- 320 people
- Sponsor
- Pfizer
Anemia, Kidney Disease, Chronic
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis
This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment.
- Trial name
- NCT01422824
- Where
- 6 sites in North Macedonia
- Volunteers
- 185 people
- Sponsor
- Hoffmann-La Roche
Renal Osteodystrophy
12-month Study of AMG 073 in Renal Osteodystrophy
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium.
- Trial name
- NCT00527085
- Testing
- AMG 073
- Volunteers
- 45 people
- Sponsor
- Amgen
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
- Trial name
- NCT01785849
- Testing
- Etelcalcetide
- Where
- 118 sites in United States, Australia and 13 more
- Volunteers
- 508 people
- Sponsor
- Amgen
Venous Stenosis, Venous Occlusion
The Merit WRAPSODY Central Feasibility Study
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins
- Trial name
- WAVE Central (NCT04541576)
- Testing
- Merit WRAPSODY Endovascular Stent Graft
- Sponsor
- Merit Medical Systems, Inc.
Moderate to Severe Secondary Hyperparathyroidism, Stage 5 Chronic Kidney Diseases
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
- Trial name
- NCT01506947
- Testing
- Paricalcitol, Darbepoetin alfa
- Volunteers
- 65 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Uremic Pruritus
TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
This study is a 2-part study. Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require…
- Trial name
- NCT03002233
- Testing
- TRK-820
- Where
- 2 sites in Bulgaria, Germany
- Volunteers
- 23 people
- Sponsor
- Toray Industries, Inc
End Stage Renal Disease
Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.
- Trial name
- NCT02378350
- Testing
- Hemodialysis treatment (no specific device is defined), Peritoneal Dialysis treatment (no specific drug is defined)
- Where
- 21 sites in China
- Volunteers
- 668 people
- Sponsor
- Vantive Health LLC
Anemia of Chronic Kidney Disease
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to…
- Trial name
- NCT02805244
- Testing
- JTZ-951, 14C-JTZ-951
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shionogi Inc.
End Stage Renal Disease
Solv Multi-Pass Hemodialysis System In-Center Clinical Study
Solv In-Center clinical study is a pre-market, prospective, multicenter, single arm, open-label clinical study. The patient population will include patients with kidney failure or insufficiency requiring hemodialysis and/or…
- Trial name
- NCT07216885
- Testing
- Solv Multi-Pass Hemodialysis System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Mozarc Medical US LLC
Anemia
A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia
This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia.
- Trial name
- NCT00605293
- Testing
- methoxy polyethylene glycol-epoetin beta, Epoetin alfa
- Where
- 19 sites in Spain
- Volunteers
- 101 people
- Sponsor
- Hoffmann-La Roche
End Stage Renal Disease, Hyperphosphatemia
A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia
- Trial name
- NCT02469467
- Testing
- VS-505
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- KDL Inc.
Secondary Hyperparathyroidism
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to < 18 years of age, with chronic…
- Trial name
- NCT03969329
- Testing
- Etelcalcetide
- Where
- 23 sites in Belgium, Czechia and 10 more
- Volunteers
- 24 people
- Sponsor
- Amgen
Anaemia
A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
This study is to evaluate the efficacy and safety of QLG1218(daprodustat) following a switch from erythropoiesis-stimulating agent (ESA) in Chinese HD subjects with renal anemia who are currently treated with ESA.
- Trial name
- NCT07300111
- Testing
- Daprodustat, Darbepoetin alfa
- Volunteers
- 100 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Anemia
MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia.
- Trial name
- NCT00545571
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 27 sites in Austria, Switzerland
- Volunteers
- 120 people
- Sponsor
- Hoffmann-La Roche
Vascular Diseases, Peripheral Arterial Disease
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
- Conditions
- Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases
- Trial name
- PHOTO-V (NCT03669042)
- Testing
- PhotoFix
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Artivion Inc.