Clinical trials: Hemodialysis
End Stage Renal Disease
Evaluation of STARgraft-2 for Hemodialysis Access
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft.
- Trial name
- NCT04783779
- Testing
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Healionics Corporation
End-Stage Renal Disease
Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis
This study is to evaluate the safety and tolerability of the AKST1210 column at blood-flow rates greater than 250 mL/min in subjects with end-stage renal disease (ESRD) undergoing hemodialysis (HD).
- Trial name
- NCT04985383
- Testing
- AKST1210 S-15 at 250 mL/min, AKST1210 S-15 at 450 mL/min, AKST1210 S-25 at 250 mL/min
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Alkahest, Inc.
Chronic Kidney Diseases, Pruritus
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
- NCT05342623
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 83 sites in United States
- Volunteers
- 286 people
- Sponsor
- Cara Therapeutics, Inc.
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal…
- Trial name
- NCT04064827
- Testing
- Paricalcitol
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- AbbVie
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis
To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM)…
- Trial name
- NCT02015780
- Testing
- Fasiglifam, Antihyperglycemic therapy
- Where
- 30 sites in United States, Bulgaria and 5 more
- Sponsor
- Takeda
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- W.L.Gore & Associates
Secondary Hyperparathyroidism
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney…
- Trial name
- NCT01414114
- Testing
- Etelcalcetide
- Volunteers
- 37 people
- Sponsor
- KAI Pharmaceuticals
Chronic Kidney Disease
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.
- Trial name
- NCT00267514
- Testing
- sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®), sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
- Where
- 7 sites in United Kingdom
- Volunteers
- 31 people
- Sponsor
- Genzyme, a Sanofi Company
Anemia
A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients 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 patients with chronic renal anemia.
- Trial name
- NCT00560547
- Testing
- methoxy polyethylene glycol-epoetin beta
- Where
- 3 sites in Denmark
- Sponsor
- Hoffmann-La Roche
Hemodialysis Patients
Correction Study of R744 in Renal Anemia Patients on Hemodialysis
This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.
- Trial name
- NCT00433693
- Testing
- R744
- Where
- 6 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Chugai Pharmaceutical
Acute Kidney Injury, Fluid Overload
Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system.
- Trial name
- NCT04608149
- Testing
- Carpediem System
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Mozarc Medical US LLC
Hemolysis, COVID-19
Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
- Trial name
- NCT05480436
- Testing
- coadministration, COVID-19 vaccine, IIV4+PPV23
- Where
- 3 sites in China
- Volunteers
- 1,200 people
- Sponsor
- China National Biotec Group Company Limited
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
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
Dialysis, Anemia
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
- Trial name
- NCT01414075
- Testing
- Roxadustat, Oral Iron, IV Iron
- Where
- 7 sites in United States, Hong Kong and 2 more
- Volunteers
- 60 people
- Sponsor
- Kyntra Bio
Secondary Hyperparathyroidism
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism…
- Trial name
- NCT03822507
- Testing
- KHK7580, Cinacalcet Hydrochloride
- Where
- 34 sites in China, Hong Kong and 2 more
- Volunteers
- 404 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Uremic Pruritus
A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet
This is a multisite study to evaluate the efficacy, safety and plasma concentration of Nalfurafine Hydrochloride orally disintegrating tablet in the treatment of refractory pruritus in maintenance hemodialysis patients, and to…
- Trial name
- NCT04728984
- Testing
- Nalfurafine Hydrochloride
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Renal Dialysis
End-stage Renal Disease (ESRD) Pilot Study
The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD).
- Trial name
- NCT03787368
- Testing
- BAY1213790, 0.9% sodium chloride solution
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 55 people
- Sponsor
- Bayer
Anemia of Chronic Kidney Disease
CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis
The aim of this study was to compare and evaluate efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis.
- Trial name
- NCT03428594
- Testing
- CKD-11101, NESP
- Volunteers
- 403 people
- Sponsor
- Chong Kun Dang Pharmaceutical
End Stage Renal Disease
Evaluation of STARgraft AV for Hemodialysis Access
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft.
- Trial name
- NCT03916731
- Testing
- STARgraft AV, ePTFE AV graft (control)
- Where
- Paraguay
- Volunteers
- 55 people
- Sponsor
- Healionics Corporation