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Ferric Citrate Phase III in ESRD
NCT01503736Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2010
- Primary completion
- Jun 2012
- Countries
- 1
- Sponsor
- Panion & BF Biotech Inc.
- Modality
- Small Molecules
- Drugs
- ferric citrate
- Conditions
- hyperphosphatemia
01
Overview
Phase 3, randomised, double-blind trial of ferric citrate in hyperphosphatemia (3 arms), sponsored by Panion & BF Biotech Inc. Primary endpoint: Change in serum phosphorus at Day 56 as compared to baseline. Started Jun 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo TID
4g/day
Ferric Citrate 4g/day TID
6g/day
Ferric Citrate 6g/day TID
03
Endpoints
Primary
Change in serum phosphorus at Day 56 as compared to baseline
Secondary
Change in serum phosphorus at Day 28 as compared to baseline
Change in Ca x P product at Day 56 compared to baseline
Change in Ca x P product at Day 28 compared to baseline
Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56
Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28
04
Results
Primary endpoints met
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