Clinical trials: Haemodialysis Complication
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard
Anemia, Hemodialysis
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.
- Conditions
- Anemia, Hemodialysis, Renal Impairment
- Trial name
- NCT01083888
- Testing
- roxadustat
- Where
- Japan
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Inc
End Stage Renal Disease
Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels
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) to K/DOQI recommended targets in subjects with end stage…
- Trial name
- NCT00113958
- Testing
- Cinacalcet
- Sponsor
- Amgen
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
End Stage Renal Failure, Hemodialysis, Cannulation
Guided Needle Insertion for Vascular Access
The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment.
- Trial name
- ACCESS 2 (NCT07548151)
- Testing
- Ultrasound-Guided, Power-Assisted Needle Insertion
- Where
- Uzbekistan
- Volunteers
- 10 people
- Sponsor
- X9, Inc.
Acute Kidney Failure, Chronic Kidney Diseases
Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
- Trial name
- NCT06358365
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- AquaPass Medical Ltd.
Chronic Kidney Disease, End-stage Renal Disease
MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring…
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease, Anaemia
- Trial name
- MONITOR-CKD5 (NCT01121237)
- Testing
- Recombinant human erythropoietin alfa (biosimilar)
- Where
- 95 sites in Austria, France and 8 more
- Volunteers
- 2,086 people
- Sponsor
- Sandoz
Renal Anemia Associated With Chronic Renal Failure (CRF)
A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug
This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.
- Trial name
- NCT01888445
- Testing
- roxadustat, darbepoetin alfa
- Where
- 8 sites in Japan
- Volunteers
- 130 people
- Sponsor
- Astellas Pharma Inc
Chronic Kidney Diseases, End Stage Renal Disease
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a…
- Conditions
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure
- Trial name
- SAVE-FistulaS (NCT06001827)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control
- Where
- 28 sites in United States
- Volunteers
- 600 people
- Sponsor
- VenoStent
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
- Trial name
- NCT01788046
- Testing
- Etelcalcetide
- Where
- 106 sites in United States, Australia and 13 more
- Volunteers
- 515 people
- Sponsor
- Amgen
End Stage Renal Disease
Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China
Primary Objective: The primary objective is to prospectively assess and compare survival in subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or Hemodialysis (HD) treatment.
- Trial name
- NCT01413074
- Testing
- Peritoneal Dialysis treatment, Hemodialysis treatment
- Where
- 7 sites in China
- Volunteers
- 416 people
- Sponsor
- Vantive Health LLC
Anemia, Chronic Kidney Disease
Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
The purpose of this study was to determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin (alfa…
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Trial name
- NCT00434330
- Testing
- peginesatide
- Where
- 15 sites in Bulgaria, Romania and 1 more
- Volunteers
- 91 people
- Sponsor
- Affymax
Renal Disease
A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Ceftaroline in a group of patients with renal disease and matching healthy subjects with normal renal function
- Trial name
- NCT01664065
- Testing
- 200 mg Ceftaroline fosamil, 600 mg Ceftaroline fosamil
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Pfizer
Kidney Failure, Chronic, Hemodialysis
Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure
To verify the efficacy of recombinant erythropoiesis stimulating protein injection (CHO cell) in hemodialysis patients with chronic renal failure anemia maintenance treatment is not inferior to yibio.
- Trial name
- NCT05211167
- Testing
- Human Erythropoiesis Injection (CHO cell), Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
End Stage Renal Disease
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to…
- Trial name
- NCT06329310
- Testing
- aXess-E conduit
- Where
- 2 sites in Portugal, Serbia
- Volunteers
- 20 people
- Sponsor
- Xeltis
Chronic Kidney Disease, End-Stage Renal Disease
The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis
This trial is conducted in Africa, Asia, Europe, North and South America and Oceania. The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health…
- Trial name
- OPPORTUNITY (NCT00503698)
- Testing
- somatropin
- Where
- 381 sites in United States, Argentina and 19 more
- Volunteers
- 712 people
- Sponsor
- Novo Nordisk A/S
Staphylococcal Infections, Kidney Failure, Chronic
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.
- Trial name
- NCT00071214
- Testing
- S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
- Volunteers
- 3,600 people
- Sponsor
- Nabi Biopharmaceuticals
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
Kidney Disease, Secondary Hyperparathyroidism
START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
The purpose of this research is to study the effects and safety of Sensipar approved by the Food and Drug Administration (FDA) in patients with kidney failure who are being treated with dialysis and have uncontrolled secondary…
- Conditions
- Kidney Disease, Secondary Hyperparathyroidism, Chronic Kidney Disease
- Trial name
- NCT00132431
- Testing
- Sensipar
- Volunteers
- 300 people
- Sponsor
- Amgen
ESRD, Hemodialysis
The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment
This is a prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study…
- Trial name
- NCT04868643
- Testing
- The DIMI Renal Replacement Therapy (RRT) System
- Sponsor
- Dialco Medical Inc.