Clinical trials: Hemodialysis Complication
End Stage Renal Disease, Thrombosis
Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis
This study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts.
- Trial name
- NCT03963895
- Testing
- AB002 Dose 1, AB002 Dose 2
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Aronora, Inc.
Chronic Kidney Disease
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis [HD]) and to assess the safety, tolerability, and…
- Trial name
- NCT02837237
- Testing
- KBP-5074
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- KBP Biosciences
Hyperparathyroidism, Secondary
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
- Trial name
- NCT01932970
- Testing
- Etelcalcetide
- Where
- 40 sites in United States
- Volunteers
- 158 people
- Sponsor
- Amgen
Cognitive Impairment, End Stage Renal Disease
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
This study will evaluate the tolerability, feasibility, and efficacy of the AKST1210 column in subjects with end-stage renal disease with cognitive impairment (ESRD-CI) undergoing hemodialysis 3 times per week.
- Trial name
- NCT04527328
- Testing
- AKST1210, Hemodialysis
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Alkahest, Inc.
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
- Trial name
- NCT01785875
- Testing
- Etelcalcetide
- Where
- 208 sites in United States, Australia and 15 more
- Volunteers
- 891 people
- Sponsor
- Amgen
Staphylococcal Infections, Chronic Kidney Failure
Evaluation of Manufacturing Lot of StaphVAX
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine.
- Trial name
- NCT00211900
- Testing
- S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Nabi Biopharmaceuticals
Kidney Failure, Chronic
Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects
A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal function.
- Trial name
- NCT02022748
- Testing
- ticagrelor
- Where
- 2 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Anemia, Kidney Failure
Dynepo Infrequent Dosing Study
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and…
- Trial name
- NCT00450333
- Testing
- Dynepo (Epoetin delta), Dynepo
- Where
- 53 sites in Austria, Belgium and 5 more
- Volunteers
- 407 people
- Sponsor
- Shire
CKD, ESRD
Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)
The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.
- Trial name
- LTHD PMCF (NCT04782297)
- Testing
- Long term hemodialysis catheter
- Where
- 2 sites in United States, Spain
- Sponsor
- Medical Components, Inc dba MedComp
Chronic Kidney Diseases, Pruritus
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in…
- Trial name
- NCT05356403
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 75 sites in United States, Argentina and 11 more
- Volunteers
- 105 people
- Sponsor
- Cara Therapeutics, Inc.
Chronic Kidney Disease
A Study of LY3113593 in Participants With Chronic Kidney Disease
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes…
- Trial name
- NCT02604160
- Testing
- LY3113593
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company
End Stage Kidney Disease, Chronic Kidney Diseases
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in…
- Conditions
- End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure, Kidney Insufficiency
- Trial name
- WAVE-Global (NCT04626427)
- Testing
- WavelinQ™ EndoAVF System
- Where
- 3 sites in Belgium, Greece and 1 more
- Volunteers
- 21 people
- Sponsor
- C. R. Bard
Multiple Myeloma, Renal Impairment
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and…
- Trial name
- POM Renal (NCT01575925)
- Testing
- 4 mg Oral POM + 40 mg Oral DEX, 2 mg Oral POM + 40 mg Oral DEX
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Celgene
Cytomegalovirus (CMV), Kidney Disease
A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis).
- Conditions
- Cytomegalovirus (CMV), Kidney Disease, Kidney Failure
- Trial name
- NCT06243731
- Testing
- No Intervention
- Where
- 25 sites in Belgium, Estonia and 5 more
- Volunteers
- 10 people
- Sponsor
- Takeda
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
End Stage Renal Disease (ESRD)
Multi-Site STARgraft (10401) Trial
This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft…
- Trial name
- NCT07557862
- Testing
- STARgraft (10401), Gore Propaten
- Where
- 7 sites in Brazil, Colombia
- Volunteers
- 111 people
- Sponsor
- Healionics Corporation
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
Chronic Kidney Disease
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel.
- Trial name
- NCT00679991
- Testing
- PRT-201
- Where
- 11 sites in United States
- Volunteers
- 66 people
- Sponsor
- Proteon Therapeutics
Secondary Hyperparathyroidism
A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis
- Trial name
- NCT02133404
- Testing
- ASP7991, Cinacalcet
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal…
- Trial name
- AiME - 04 (NCT01628120)
- Testing
- Epoetin Hospira
- Where
- 115 sites in United States
- Volunteers
- 170 people
- Sponsor
- Pfizer