Clinical trials: Hemodialysis
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
End Stage Renal Disease
Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based…
- Trial name
- NCT01130831
- Testing
- Lanthanum carbonate
- Where
- 31 sites in Germany
- Volunteers
- 66 people
- Sponsor
- Shire
Chronic Kidney Failure, Secondary Hyperparathyroidism
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product…
- Trial name
- NCT01081665
- Where
- 19 sites in Greece
- Volunteers
- 237 people
- Sponsor
- Abbott
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
Venous Stenosis, Venous Occlusion
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
- Trial name
- WAVE (NCT04540302)
- Testing
- Merit WRAPSODY Endovascular Stent Graft, PTA
- Where
- 43 sites in United States, Brazil and 2 more
- Volunteers
- 357 people
- Sponsor
- Merit Medical Systems, Inc.
Kidney Failure, Chronic
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease…
- Trial name
- LEAP (NCT00853242)
- Testing
- Genz-644470, Sevelamer carbonate
- Where
- 53 sites in United States, Puerto Rico
- Volunteers
- 349 people
- Sponsor
- Genzyme, a Sanofi Company
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
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
Hemodialysis, Hyperphosphatemia
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
- Trial name
- NCT01850641
- Testing
- PA21
- Where
- Japan
- Volunteers
- 35 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Hemodialysis Graft Dysfunction
Use of ABI-007 for the Prevention of Vascular Access Graft Failure in Patients Undergoing Hemodialysis
This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for hemodialysis patients with vascular access device failure, and to obtain preliminary data on the effectiveness of such treatment.
- Trial name
- NCT00249002
- Testing
- ABI-007
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Celgene
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
Anaemia
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in…
- Trial name
- NCT01977482
- Testing
- GSK1278863, rhEPO
- Where
- 107 sites in United States, Australia and 14 more
- Volunteers
- 216 people
- Sponsor
- GlaxoSmithKline
Hyperkalemia
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
- Trial name
- NCT02033317
- Testing
- patiromer
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Relypsa, Inc.
Renal Dialysis
Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis
Pilot-scale study to assess the effect of self-monitoring using the patientMpower electronic health journal (pMp app) [+digital weighing scales \& BP monitor] on outcomes in ambulatory haemodialysis patients.
- Trial name
- NCT03403491
- Testing
- patientMpower application
- Where
- Ireland
- Volunteers
- 43 people
- Sponsor
- patientMpower Ltd.
Chronic Renal Failure
Use Of Fragmin In Hemodialysis
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
- Trial name
- NCT01879618
- Testing
- Fragmin
- Where
- 19 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Pfizer
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.
Kidney Failure, Chronic, Catheter-Related Infections
Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
- Trial name
- NCT02651428
- Testing
- Neutrolin, Heparin
- Where
- 5 sites in United States
- Volunteers
- 806 people
- Sponsor
- CorMedix Therapeutics
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
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients…
- Trial name
- AiME - 03 (NCT01628107)
- Testing
- Epoetin Hospira
- Where
- 110 sites in United States, Puerto Rico
- Volunteers
- 406 people
- Sponsor
- Pfizer
Secondary Hyperparathyroidism, Chronic Kidney Disease
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with…
- Trial name
- NCT01896232
- Testing
- Etelcalcetide, Cinacalcet
- Where
- 182 sites in United States, Austria and 20 more
- Volunteers
- 683 people
- Sponsor
- Amgen