Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
- Conditions
- Chronic Kidney Failure
- Interventions
- Registration Number
- NCT00841126
- Lead Sponsor
- Ineos Healthcare Limited
- Brief Summary
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 hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.
- Detailed Description
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 1.78 mmol/L in patients who receive hemodialysis.
This is a 2-stage re-randomization design where Stage 1 is a randomized, open label comparison between fermagate and lanthanum carbonate (in a non-inferiority design) and Stage 2 is a randomized double blind comparison between fermagate and placebo (in a superiority design).
Objectives at Stage 1:
Primary Objective:
The primary objective is to establish the efficacy of fermagate by demonstrating the noninferiority (with possible assessment of superiority) of fermagate to lanthanum carbonate in lowering serum phosphate in hemodialysis patients.
Secondary objectives:
The secondary objectives are to:
1. Determine the safety of fermagate in hemodialysis patients.
2. Compare the effects of fermagate and lanthanum carbonate on measures of mineral metabolism, albumin, pre-albumin and iron status.
Objectives at Stage 2:
Stage 2 will use patients who complete the 3-month maintenance period of Stage 1 and who were originally randomized to fermagate.
Primary Objective:
The primary objective is to establish efficacy of fermagate by demonstrating the superiority of fermagate over placebo in lowering serum phosphate in hemodialysis patients.
Secondary objectives:
The secondary objectives are to:
1. Determine the safety of fermagate in hemodialysis patients.
2. Compare the effects of fermagate and placebo on measures of mineral metabolism, albumin, pre-albumin and iron status.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 657
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Magnesium iron hydroxycarbonate Magnesium iron hydroxycarbonate - Lanthanum carbonate Lanthanum carbonate -
- Primary Outcome Measures
Name Time Method Stage 1: Control or not the level of serum phosphate Within the treatment period Stage 2: Change from treated baseline in mean serum phosphate At 4 weeks
- Secondary Outcome Measures
Name Time Method Stage 2: Change from treated baseline in mean serum phosphate At weeks 1, 2 and 3 Stage 2: Change from treated baseline in Ca, Ca-phosphate product and PTH levels At the end of weeks 1, 2, 3 and 4 Stage 1: Change from baseline in calcium, calcium phosphate product and PTH level End of 3 months treatment in maintenance period Stage 1: Change from baseline in mean serum phosphate End of 3 months treatment in maintenance period
Trial Locations
- Locations (105)
Nephrology Associates PC
🇺🇸Birmingham, Alabama, United States
Arizona Kidney Disease and Hypertension Center
🇺🇸Phoenix, Arizona, United States
Southwest Kidney Institute
🇺🇸Tempe, Arizona, United States
US Renal Care
🇺🇸Mansfield, Texas, United States
Wright Steven (Private Practice)
🇺🇸Pine Bluff, Arkansas, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Apex Research of Riverside
🇺🇸Riverside, California, United States
North America Research Institute
🇺🇸San Dimas, California, United States
Kidney Center Inc.
🇺🇸Simi Valley, California, United States
Nephrology Educational Services and Research
🇺🇸Tarzana, California, United States
Scroll for more (95 remaining)Nephrology Associates PC🇺🇸Birmingham, Alabama, United States