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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 4g/day | Experimental | Ferric Citrate for a total daily dose of 4g |
|
| 6g/day | Experimental | Ferric Citrate for a total daily dose of 6g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferric citrate | Drug | 0g/day ferric citrate capsule, TID for 56 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum phosphorus at Day 56 as compared to baseline | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital | Kaohsiung City | Taiwan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24840781 | Result | Lee CT, Wu IW, Chiang SS, Peng YS, Shu KH, Wu MJ, Wu MS. Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study. J Nephrol. 2015 Feb;28(1):105-13. doi: 10.1007/s40620-014-0108-6. Epub 2014 May 20. | |
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
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| ferric citrate |
| Drug |
4g/day ferric citrate capsule, TID for 56 days |
|
| ferric citrate | Drug | 6 g/day ferric citrate capsule, TID for 56 days |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D010760 | Phosphorus Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C025314 | ferric citrate |
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