| Trial ID: | L1074 |
| Source ID: | NCT01503736
|
| Associated Drug: |
Ferric Citrate
|
| Title: |
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperphosphatemia|End Stage Renal Disease|ESRD
|
| Interventions: |
DRUG: ferric citrate|DRUG: ferric citrate|DRUG: ferric citrate
|
| Outcome Measures: |
Primary: Change in serum phosphorus at Day 56 as compared to baseline, Day 56 | Secondary: Change in serum phosphorus at Day 28 as compared to baseline, Day 28|Change in Ca x P product at Day 56 compared to baseline, Day 56|Change in Ca x P product at Day 28 compared to baseline, Day 28|Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56, Day 56|Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28, Day 28
|
| Sponsor/Collaborators: |
Sponsor: Panion & BF Biotech Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
183
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-06
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2020-01-13
|
| Locations: |
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital, Kaohsiung, Taiwan|Division of Nephrology, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan|Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital, New Taipei City, Taiwan|Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan|Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
|
| URL: |
https://clinicaltrials.gov/show/NCT01503736
|
