Chronic Kidney Failure Clinical Trial
Official title:
An Open, Randomised, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride in Haemodialysis Patients With Hyperphosphataemia
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food,
reducing the amount that the body can absorb.
The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in
subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer
hydrochloride.
High levels of phosphate in the blood are linked with serious effects, due to calcium
imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium
deposites in the body and blood-vessel disease.
Current guidelines indicate that blood phosphorous levels should be maintained between 1.13
to 1.78mmol/L in patients who receive haemodialysis.
The purpose of this study is to establish the non-inferiority of magnesium iron
hydroxycarbonate to sevelamer hydrochloride in lowering serum phosphate in haemodialysis
patients treated for 3 months. Additional objectives: (1) to determine the safety of
magnesium iron hydroxycarbonate after short term (3 months) and long term (6 and 12 months)
treatment, (2)to determine the efficacy of magnesium iron hydroxycarbonate after long term
treatment (6 and 12 months) and (3) To compare the effects of magnesium iron
hydroxycarbonate and sevelamer hydrochloride on measures of mineral metabolism, albumin,
pre-albumin and iron status after short term (3 months) and long term (6 and 12 months)
treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
| Completed |
NCT00806130 -
Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
|
||
| Completed |
NCT00781690 -
Reduction of Heparin Dose in Dialysis With Evodial System
|
N/A | |
| Completed |
NCT00153621 -
Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients
|
N/A | |
| Completed |
NCT06165211 -
Nature-Based Sound Application For Hemodialysis Patients
|
N/A | |
| Not yet recruiting |
NCT04013620 -
CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction
|
Phase 3 | |
| Withdrawn |
NCT03998917 -
Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
|
||
| Completed |
NCT02586376 -
Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF)
|
N/A | |
| Completed |
NCT00794326 -
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
|
Phase 3 | |
| Completed |
NCT05185999 -
Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients
|
Phase 1 | |
| Completed |
NCT03076528 -
An Innovative Virtually Supervised Exercise for Dialysis Patients
|
Phase 2 | |
| Completed |
NCT02513303 -
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
|
Phase 3 | |
| Unknown status |
NCT00788905 -
Comparison of Conventional Dialysis and the Allient System
|
N/A | |
| Completed |
NCT00804453 -
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
|
N/A | |
| Completed |
NCT01085552 -
Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
|
Phase 1 | |
| Completed |
NCT00694824 -
Vascular Calcification's Risk Factors in Haemodialysis Patients
|
||
| Completed |
NCT00074620 -
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
|
Phase 2 | |
| Withdrawn |
NCT06030050 -
Animal Assisted Intervention for Hemodialysis Outpatients
|
N/A | |
| Recruiting |
NCT05562869 -
Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
|
Phase 3 | |
| Completed |
NCT03437538 -
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
|
N/A |