Clinical trials: End-stage Disease
Kidney Failure, Chronic
Clinical Study to Assess the Performance of the Dialyzer With Endexo™
Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is…
- Trial name
- NCT03536663
- Testing
- Optiflux and Dialyzer with Endexo
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Fresenius Medical Care North America
Cardiovascular Disease, Chronic Kidney Failure
Effect of HCO1100 on Cardiovascular Function
The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.
- Trial name
- HicoCARD (NCT01363921)
- Testing
- HCO 1100
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Vantive Health LLC
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
End Stage Renal Disease
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on…
- Trial name
- NCT01195246
- Testing
- HEPLISAV, Engerix-B, Fendrix
- Where
- 19 sites in Germany
- Volunteers
- 155 people
- Sponsor
- Dynavax Technologies Corporation
Healthy Volunteers
Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548
The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.
- Trial name
- NCT02327546
- Testing
- AKB-6548, Ferrous Sulfate
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Renal Impairment
Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment
The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal.
- Trial name
- NCT01613690
- Testing
- NVA237
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease (ESRD), Diabetes
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients…
- Conditions
- End Stage Renal Disease (ESRD), Diabetes, CAPD
- Trial name
- EDEN (NCT01219959)
- Testing
- Dianeal, Dianeal, Extraneal, Nutrineal
- Where
- 16 sites in Colombia
- Volunteers
- 71 people
- Sponsor
- Vantive Health LLC
Renal Impairment, End-stage Renal Disease
An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
- Trial name
- NCT02397395
- Testing
- Simeprevir (SMV) 150 mg, Daclatasvir (DCV) 60 mg
- Where
- 6 sites in France, Spain
- Sponsor
- Janssen R&D Ireland
End-Stage Kidney Disease
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to…
- Trial name
- NCT00062699
- Testing
- Zemplar (paricalcitol injection), Calcijex
- Where
- 60 sites in United States
- Volunteers
- 2,200 people
- Sponsor
- Abbott
Age Related Macular Degeneration
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
- Trial name
- NCT01731964
- Testing
- Telescope prosthesis, WA-NG Telescope Prothesis
- Where
- Israel
- Sponsor
- VisionCare, Inc.
End Stage Macular Degeneration
A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD
Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use.
- Trial name
- NCT00555165
- Testing
- Telescope prosthesis
- Where
- 4 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- VisionCare, Inc.
Renal Insufficiency
Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects
The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population.
- Trial name
- NCT03087942
- Testing
- QAW039, QAW39A, QAW39A2107
- Where
- 2 sites in United States, Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease on Dialysis (Diagnosis)
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
The aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of Renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with…
- Trial name
- NCT03807583
- Testing
- Aminoven 10%, RENORAL
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Indigo Therapeutics
Kidney Failure, Chronic
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate
- Trial name
- NCT00151931
- Testing
- Lanthanum carbonate
- Volunteers
- 456 people
- Sponsor
- Shire
Kidney Disease, End-Stage
PATH-03 Paraguay Feasibility Study
The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
- Trial name
- NCT07034092
- Testing
- ePATH System will be used to create an endoAVF
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Pathfinder Medical
SARS-CoV-2 Infection (Asymptomatic), SARS-CoV-2 Infection (Symptomatic)
COVID-19 Progression in End-Stage Kidney Disease
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
- Trial name
- COPE (NCT04495907)
- Where
- 11 sites in United States
- Volunteers
- 412 people
- Sponsor
- Davita Clinical Research
Kidney Transplantation in Highly Sensitized Patients
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
- Trial name
- DINKY (NCT05753930)
- Testing
- Imlifidase
- Where
- 6 sites in Finland, France and 3 more
- Volunteers
- 10 people
- Sponsor
- Hansa Biopharma AB
End Stage Renal Disease, Hyperphosphatemia
Phosphate Kinetic Modeling
Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is associated with widespread vascular calcification.
- Trial name
- PKM (NCT01003223)
- Testing
- Computer algorithm management of hyperphosphatemia
- Where
- United States
- Volunteers
- 190 people
- Sponsor
- Fresenius Medical Care North America
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
End Stage Renal Disease
Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm.
- Trial name
- NCT01395823
- Testing
- ergocalciferol supplementation
- Where
- 12 sites in United States
- Volunteers
- 470 people
- Sponsor
- Dialysis Clinic, Inc.