Clinical trials: Hemodialysis Patient
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
Anemia of Chronic Kidney Disease
Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
Anticalin® proteins are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of…
- Trial name
- NCT03325621
- Testing
- PRS-080#022-DP
- Where
- 6 sites in Czechia, Germany
- Volunteers
- 11 people
- Sponsor
- Pieris Pharmaceuticals GmbH
End Stage Renal Disease, Hemodialysis Access Failure
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices.
- Trial name
- PReSeRVE-HD (NCT06422871)
- Testing
- HeRO® Graft System or Super HeRO® System
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Merit Medical Systems, Inc.
Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991
Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.
- Conditions
- Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy, Pharmacodynamics of ASP7991, Pharmacokinetics of ASP7991
- Trial name
- NCT01872026
- Testing
- ASP7991
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Astellas Pharma Inc
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
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.
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.
Hyperphosphatemia Patients on Hemodialysis
A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.
- Trial name
- NCT07285304
- Testing
- TS-172
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Hemodialysis, Healthy
Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects
The objectives of this study are to evaluate the in vivo metabolite profiling and characterization of CR845 administered intravenously (IV) in patients on hemodialysis (HD) and in healthy subjects; and to determine the…
- Trial name
- NCT03947970
- Testing
- [14C] CR845
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cara Therapeutics, Inc.
Kidney Failure, Chronic
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease…
- Trial name
- LEAP (NCT00853242)
- Testing
- Genz-644470, Sevelamer carbonate
- Where
- 53 sites in United States, Puerto Rico
- Volunteers
- 349 people
- Sponsor
- Genzyme, a Sanofi Company
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
Hemodialysis, Hyperphosphatemia
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
- Trial name
- NCT01850602
- Testing
- PA21, Sevelamer hydrochloride
- Where
- Japan
- Volunteers
- 213 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Hemodialysis Patients
The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients
A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients
- Trial name
- NCT04195919
- Testing
- Evogliptin 5mg
- Where
- South Korea
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
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
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
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.