Clinical trials: Maintenance Hemodialysis
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.
Hypertension
Efficacy and Safety of Telmisartan in Hypertensive Patients With Mild/Moderate or Severe Renal Impairment or Requiring Hemodialysis
To evaluate the safety and efficacy, in particular with regard to renal function of telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to endstage renal impairment after 12 weeks of treatment
- Trial name
- ESPRIT (NCT02178306)
- Testing
- Telmisartan low dose, Telmisartan high dose
- Volunteers
- 82 people
- Sponsor
- Boehringer Ingelheim
Anemia, Renal Insufficiency, Chronic
Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose.
- Trial name
- DIALOGUE5 (NCT02064426)
- Testing
- Molidustat (BAY85-3934), Epoetin alfa/beta
- Where
- 26 sites in United States, Japan
- Volunteers
- 88 people
- Sponsor
- Bayer
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
Anemia
A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis…
- Trial name
- CARISMA (NCT00699348)
- Testing
- Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
- Where
- 60 sites in Italy
- Volunteers
- 351 people
- Sponsor
- Hoffmann-La Roche
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.
Anemia
Study of SAL-0951 Compared to Recombinant Human Erythropoietin in Anemic Patients Receiving Maintenance Hemodialysis
The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in Chinese patients undergoing maintenance hemodialysis with chronic kidney disease and anemia，who are receiving stable treatment with erythropoietic…
- Trial name
- NCT06720025
- Testing
- SAL-0951 tablets, rHuEPO injection
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis, End Stage Renal Disease on Dialysis
- Trial name
- NCT06712654
- Testing
- AP306 75 mg BID, AP306 125 mg BID, AP306 150 mg BID
- Where
- 31 sites in United States, China
- Volunteers
- 168 people
- Sponsor
- R1 Therapeutics
Hyperkalemia
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.
- Trial name
- PORTEND (NCT02609841)
- Testing
- Cardiac rhythm remote monitoring system
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- ZS Pharma, Inc.
Anemia
Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)
This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current…
- Trial name
- NCT04313153
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 59 sites in United States, Czechia and 4 more
- Volunteers
- 319 people
- Sponsor
- Akebia Therapeutics
Renal Dialysis
Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes.
- Trial name
- NCT06376968
- Testing
- BioLogic Fusion
- Where
- Italy
- Volunteers
- 56 people
- Sponsor
- B.Braun Avitum AG
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
Chronic Kidney Disease, Secondary Hyperparathyroidism
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
- Trial name
- NCT02833857
- Testing
- Etelcalcetide
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 11 people
- Sponsor
- Amgen
Anemia, Chronic Kidney Disease
A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)
This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating…
- Trial name
- NCT00924781
- Testing
- MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
- Volunteers
- 39 people
- Sponsor
- Merck Sharp & Dohme 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
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities
This is a multicenter, prospective, observational real-world study designed to evaluate clinical effectiveness, quality of life, and healthcare resource utilization in patients with end-stage renal disease (ESRD) initiating…
- Trial name
- NCT07781124
- Testing
- Remote patient monitoring-automated peritoneal (RPM-APD), Manual peritoneal dialysis (PD) cohort, Maintenance hemodialysis (HD)
- Where
- 20 sites in China
- Volunteers
- 750 people
- Sponsor
- Vantive Health LLC
Renal Anemia
Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)
This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity.
- Trial name
- BEAT_002 (NCT02947438)
- Testing
- EPREX®, EPIAO®
- Where
- 19 sites in Russia, Thailand
- Volunteers
- 207 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Secondary Hyperparathyroidism
A Trial of SHR6508 in Secondary Hyperparathyroidism
The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis
- Trial name
- NCT05221008
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal…
- Trial name
- AiME - 04 (NCT01628120)
- Testing
- Epoetin Hospira
- Where
- 115 sites in United States
- Volunteers
- 170 people
- 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.