A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
Study Details
Study Description
Brief Summary
The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: ferric citrate
0g/day ferric citrate capsule, TID for 56 days
|
| Experimental: 4g/day Ferric Citrate for a total daily dose of 4g |
Drug: ferric citrate
4g/day ferric citrate capsule, TID for 56 days
|
| Experimental: 6g/day Ferric Citrate for a total daily dose of 6g |
Drug: ferric citrate
6 g/day ferric citrate capsule, TID for 56 days
|
Outcome Measures
Primary Outcome Measures
- Change in serum phosphorus at Day 56 as compared to baseline [Day 56]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age>18 years and has a diagnosis of ESRD
-
On a three-times per week hemodialysis regimen
-
On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
-
If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
-
Hct >= 20%
-
Serum Ca level of 8 mg/dL to 10.5 mg/dL
Exclusion Criteria:
-
Is pregnant or lactating
-
Clinically significant GI disorder
-
Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is <7 mg/dL)
-
ferritin>800 ng/mL
-
Unstable medical condition unsuitable for the study in the opinion of investigator
-
Has been treated with an investigational agent within 30 days of enrollment
-
Has a history of documented iron allergy or hemochromatosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital | Kaohsiung | Taiwan | ||
| 2 | Division of Nephrology, Keelung Chang Gung Memorial Hospital | Keelung | Taiwan | ||
| 3 | Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital | New Taipei City | Taiwan | ||
| 4 | Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital | Taichung | Taiwan | ||
| 5 | Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- Panion & BF Biotech Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PNC00301