Clinical trials: Hemodialysis
Chronic Kidney Disease (CKD)
A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.
- Trial name
- NCT02504294
- Testing
- Epoetin Hospira Arm, Standard of Care Arm, IV Iron
- Where
- 45 sites in United States, Puerto Rico
- Volunteers
- 432 people
- Sponsor
- Pfizer
Chronic Kidney Disease
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to…
- Trial name
- COS-002 (NCT01427907)
- Testing
- Calcium acetate oral solution (COS), Sevelamer carbonate
- Where
- 4 sites in United States
- Volunteers
- 38 people
- Sponsor
- Fresenius Medical Care North America
Fluid Loss, Dialysis
Clinical Evaluation of the CM-1500 During Hemodialysis
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 20 subjects consented to undergo a hemodialysis session as a part of their standard…
- Trial name
- NCT05125848
- Testing
- CM-1500
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Zynex Monitoring Solutions
Vascular Access
Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized / open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the…
- Trial name
- ONEPOINT-01 (NCT07599085)
- Testing
- OnePoint Dialysis Cannula
- Volunteers
- 20 people
- Sponsor
- Evolve Medicus, Inc.
Chronic Inflammatory Syndrome
Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
The purpose of the study is to determine whether Viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with Chronic Inflammatory Syndrome under…
- Trial name
- NCT00978224
- Testing
- Viusid
- Where
- Cuba
- Volunteers
- 152 people
- Sponsor
- Catalysis SL
Anemia
Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients
Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron adminsitration in hemodialysis patients.
- Trial name
- NCT02337335
- Where
- Spain
- Volunteers
- 268 people
- Sponsor
- NephroCare Spain
Uremic Pruritus
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- KALM-2 (NCT03636269)
- Testing
- CR845 0.5 mcg/kg
- Where
- 92 sites in United States, Australia and 9 more
- Volunteers
- 473 people
- Sponsor
- Cara Therapeutics, Inc.
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
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Post-Approval Study for the FLAIR Endovascular Stent Graft
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
- Trial name
- RENOVA (NCT00677235)
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- C. R. Bard
Secondary Hyperparathyroidism, Chronic Kidney Disease
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who…
- Trial name
- EVOLVE (NCT00345839)
- Testing
- Cinacalcet
- Volunteers
- 3,883 people
- Sponsor
- Amgen
Uremic Pruritus, Pruritus
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe…
- Trial name
- NCT02143648
- Testing
- nalbuphine HCl ER tablets 60 mg BID, nalbuphine HCl ER tablets 120mg BID
- Where
- 47 sites in United States, Poland and 1 more
- Volunteers
- 373 people
- Sponsor
- Trevi Therapeutics
Hyperphosphatemia
BAY 77-1931 Long-term Extension From Phase II Study
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis
- Trial name
- NCT00769496
- Testing
- BAY 77-1931
- Where
- 14 sites in Japan
- Volunteers
- 145 people
- Sponsor
- Bayer
Hepatitis B
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced.
- Trial name
- NCT00291980
- Testing
- HB-AS02V vaccine, HBVAXPRO vaccine
- Where
- 28 sites in Belgium, Czechia and 1 more
- Volunteers
- 185 people
- Sponsor
- Henogen
Pruritus, Hemodialysis Patients with Moderate-to-Severe Pruritus
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients with Chronic Kidney Disease-Associated Pruritus
This is a multi-center, randomized, double-blind, placebo-controlled study. About 544 maintenance hemodialysis patients with moderate or above chronic kidney disease-associated pruritus are planned to be enrolled.
- Trial name
- NCT05135390
- Testing
- HSK21542
- Where
- 2 sites in China
- Volunteers
- 545 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
End Stage Renal Disease
New Needle for Two-Needle Hemodialysis
Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the…
- Trial name
- BME-1 (NCT01416896)
- Testing
- Hemodialysis using the standard venous needle, Hemodialysis using a new venous needle, the "BME needle"
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Biomedical Enterprises Inc
Vascular Diseases, Peripheral Arterial Disease
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
- Conditions
- Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases
- Trial name
- PHOTO-V (NCT03669042)
- Testing
- PhotoFix
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Artivion Inc.
Secondary Hyperparathyroidism, End-stage Kidney Disease (ESKD)
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-1 (NCT05832931)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 362 people
- Sponsor
- Pathalys Pharma
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
End Stage Renal Disease
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who…
- Trial name
- PRIME (NCT01286012)
- Testing
- Soluble Ferric Pyrophosphate in liquid bicarbonate, Erythrocyte Stimulating Agent (ESA), Intravenous (IV) Iron
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 108 people
- Sponsor
- Rockwell Medical Technologies, Inc.
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.