Clinical trials: Haemodialysis Complication
End Stage Kidney Disease
The Vascutek Rapidax™ II Post Market Surveillance Registry
Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.
- Trial name
- NCT01977508
- Testing
- ePTFE vascular access grafts
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Vascutek Ltd.
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
- Trial name
- SBR759 (NCT00704483)
- Testing
- SBR759, Sevelamer HCl
- Where
- 66 sites in United States, Australia and 11 more
- Volunteers
- 321 people
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901.
- Trial name
- NCT02975388
- Testing
- RO7079901
- Where
- 5 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Secondary Hyperparathyroidism, End Stage Renal Disease
A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according…
- Trial name
- NCT01149291
- Where
- 22 sites in Turkey (Türkiye)
- Volunteers
- 511 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
End Stage Renal Disease, Thrombosis
Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis
This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts.
- Trial name
- NCT03612856
- Testing
- AB023- Dose 1, AB023-Dose 2
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Aronora, Inc.
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.
- Trial name
- NCT02119845
- Testing
- Endovascular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 16 people
- Sponsor
- C. R. Bard
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
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
End Stage Renal Disease
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
- Trial name
- NCT00131872
- Testing
- Expedial Vascular Access Graft
- Where
- 8 sites in United States
- Volunteers
- 172 people
- Sponsor
- LeMaitre Vascular
End Stage Renal Disease
Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)
The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with ESRD receiving hemodialysis, on bio-intact…
- Trial name
- NCT00113945
- Testing
- Cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
Chronic Kidney Disease Requiring Hemodialysis, End Stage Renal Disease (ESRD)
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
- Trial name
- VENOS-2 (NCT06712251)
- Testing
- Velocity pAVF System
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Venova Medical
End Stage Renal Disease, Chronic Kidney Disease
Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia
The primary objectives of this study are the following: 1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with…
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease, Hyperphosphatemic, Kidney Disease
- Trial name
- NCT00530114
- Testing
- AMG 223
- Volunteers
- 167 people
- Sponsor
- Amgen
End-Stage Kidney Disease (ESKD)
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533. The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard…
- Trial name
- NCT07759167
- Testing
- REGN9933, REGN7508, REGN9533
- Where
- Belgium
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Chronic Kidney Disease
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients
The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.
- Trial name
- AHOCEP (NCT01351636)
- Testing
- Arotinolol Hydrochloride, Non arotinolol group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
Secondary Hyperparathyroidism, Chronic Kidney Disease
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with…
- Trial name
- NCT01896232
- Testing
- Etelcalcetide, Cinacalcet
- Where
- 182 sites in United States, Austria and 20 more
- Volunteers
- 683 people
- Sponsor
- Amgen
Pruritus, Kidney Failure, Chronic
An Observational Study of Pruritus Amongst Hemodialysis Patients
The purpose of this observational study is to better understand the natural history/natural course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD).
- Conditions
- Pruritus, Kidney Failure, Chronic, Hemodialysis, Chronic Disease
- Trial name
- ITCH Registry (NCT00715260)
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Acologix, Inc.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis
- Trial name
- IMPACT SHPT (NCT00977080)
- Testing
- Paricalcitol, Cinacalcet
- Where
- 83 sites in United States, Czechia and 10 more
- Volunteers
- 272 people
- Sponsor
- Abbott
Kidney Disease, Chronic Kidney Disease
Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis.
- Trial name
- NCT00096915
- Testing
- Darbepoetin Alfa
- Volunteers
- 110 people
- Sponsor
- Amgen
Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
- Trial name
- NCT01901107
- Testing
- Kiklin capsules
- Where
- 8 sites in Japan
- Volunteers
- 1,078 people
- Sponsor
- Astellas Pharma Inc
Renal Insufficiency, Kidney Diseases
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.
- Trial name
- NCT05624710
- Testing
- INCB054707
- Where
- 4 sites in United States, Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation