Clinical trials: Hemodialysis Complication
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
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
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
End-stage Renal Disease
Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease
The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other…
- Trial name
- NCT04395131
- Testing
- Clearum HF Hemodialyzer
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Mozarc Medical US LLC
Renal Failure
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.
- Trial name
- NCT00240331
- Testing
- 10mg Rosuvastatin
- Where
- 239 sites in Australia, Austria and 23 more
- Volunteers
- 2,776 people
- Sponsor
- AstraZeneca
Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Trial name
- NCT03602261
- Testing
- Calcifediol Oral Capsule
- Where
- 18 sites in United States
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Kidney Failure, Chronic
Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood
The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.
- Trial name
- NCT00150566
- Testing
- Lanthanum carbonate
- Volunteers
- 460 people
- Sponsor
- Shire
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.
Renal Failure, Acute Renal Failure
Premarket Clinical Safety Assessment of the ELISIO™-HX
The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational…
- Conditions
- Renal Failure, Acute Renal Failure, Chronic Renal Failure, Chronic Kidney Diseases
- Trial name
- NCT07058909
- Testing
- ELISIO™-HX Dialyzer
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Nipro Medical Corporation
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
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
Secondary Hyperparathyroidism, End Stage Renal Disease
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis…
- Trial name
- NCT00117052
- Testing
- cinacalcet
- Volunteers
- 673 people
- Sponsor
- Amgen
Chronic Kidney Disease, Secondary Hyperparathyroidism
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Trial name
- NCT00742716
- Testing
- CTA018 Injection
- Where
- 12 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- OPKO IP Holdings II, Inc.