Clinical trials: Hemodialysis
End Stage Renal Disease
Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis…
- Trial name
- SODIAH (NCT06341452)
- Testing
- Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control
- Where
- Czechia
- Volunteers
- 130 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End Stage Renal Disease, Chronic Kidney Disease
Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on…
- Trial name
- NCT01503021
- Testing
- SFP
- Where
- 31 sites in United States, Canada
- Volunteers
- 718 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Kidney Failure
Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients
The purpose of this study is to determine the quantity of iron derived from SFP that is transferred from the dialysate to patients during a single dialysis session.
- Trial name
- NCT01894906
- Testing
- Soluble Ferric Pyrophosphate
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Anemia
Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose…
- Trial name
- NCT00666835
- Testing
- HX575 epoetin alfa Hexal AG, ERYPO®, Janssen-Cilag
- Where
- 54 sites in Austria, Germany
- Volunteers
- 478 people
- Sponsor
- Sandoz
Chronic Kidney Disease, Hyperparathyroidism
Pediatric Chronic Kidney Disease Safety and Efficacy
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Disease
- Trial name
- NCT01277510
- Testing
- cinacalcet capsule, Standard of Care
- Where
- 51 sites in United States, Australia and 8 more
- Volunteers
- 43 people
- Sponsor
- Amgen
CKD Anemia in Stable Dialysis Patients
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.
- Trial name
- NCT02273726
- Testing
- Epoetin Alfa, Roxadustat
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 741 people
- Sponsor
- Kyntra Bio
Anaemia in Chronic Kidney Disease
A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
The purpose of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in haemodialysis patients with Chronic Kidney Disease.
- Trial name
- DINO (NCT02301026)
- Testing
- 5% Iron Isomaltoside 1000
- Where
- 2 sites in Sweden, United Kingdom
- Volunteers
- 209 people
- Sponsor
- Pharmacosmos A/S
End-Stage Renal Disease, Hemodialysis
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis.
- Trial name
- NCT01710020
- Testing
- CP-690,550
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pfizer
Secondary Hyperparathyroidism, End Stage Kidney Disease
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
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-2 (NCT05836220)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 412 people
- Sponsor
- Pathalys Pharma
Renal Failure, End Stage Renal Disease
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone…
- Trial name
- eMPORA (NCT03315624)
- Testing
- Dialyzer
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Chronic Kidney Disease-associated Pruritus
Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients
Vifor International Ltd. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.
- Trial name
- CKD (NCT05625542)
- Sponsor
- Vifor (International) Inc.
End Stage Renal Disease
Plazomicin Study in ESRD Patients Receiving IHD
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD.
- Trial name
- NCT04699656
- Testing
- Plazomicin Injection
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cipla USA Inc.
Hemodialysis Patients With Hyperphosphatemia
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.
- Trial name
- NCT01833494
- Testing
- PA21
- Where
- Japan
- Volunteers
- 161 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis
- Trial name
- IMPACT SHPT (NCT00977080)
- Testing
- Paricalcitol, Cinacalcet
- Where
- 83 sites in United States, Czechia and 10 more
- Volunteers
- 272 people
- Sponsor
- Abbott
Secondary Hyperparathyroidism
Phase 2 Study of KHK7580
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493…
- Trial name
- NCT02216656
- Testing
- KHK7580 low dose, KHK7580 middle dose, KHK7580 high dose
- Where
- Japan
- Volunteers
- 201 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Renal Failure, End Stage Renal Disease
Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration
The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil…
- Trial name
- comPERFORMStud (NCT04102280)
- Testing
- Dialyser
- Where
- 4 sites in Germany
- Volunteers
- 52 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End Stage Renal Disease
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via…
- Trial name
- NCT04042324
- Testing
- Triferic, Heparin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Rockwell Medical Technologies, Inc.
End-Stage Renal Disease
A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram…
- Trial name
- NCT02289703
- Testing
- Rivaroxaban 15 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
End Stage Renal Disease
Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]
The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity.
- Trial name
- NCT02532621
- Testing
- Venous InterGraft Connector, sutured arterial anastomosis of an implanted vascular graft for hemodialysis, hemodialysis
- Where
- 10 sites in United States
- Volunteers
- 158 people
- Sponsor
- Phraxis, Inc.
Uremic Pruritus
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
- Trial name
- NCT03998163
- Testing
- CR845 0.5 mcg/kg
- Where
- 47 sites in United States, Czechia and 2 more
- Volunteers
- 222 people
- Sponsor
- Cara Therapeutics, Inc.