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To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric citrate | Experimental | Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Citrate | Drug | Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-emergent adverse events (TEAEs) | Number of subjects with treatment-emergent adverse events (TEAEs) | 13 months |
| Percentage of subjects with treatment-emergent adverse events (TEAEs) | Percentage of subjects with treatment-emergent adverse events (TEAEs) | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Phosphorus | Serum Phosphorus will be assessed by time-course changes of serum phosphorus levels and proportion of subjects achieved target range of serum phosphorus (>=3.5 mg/dL and <=5.5. mg/dL) from baseline to the end-of-treatment. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum calcium | Time-course changes of serum calcium from baseline. | 13 months |
| Intact plasma parathyroid hormone (iPTH) | Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline. |
Inclusion Criteria:
Exclusion Criteria:
Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:
i. Is allergic to ferric citrate ii. Has hypophosphatemia iii. Has hemochromatosis or iron overload syndromes iv. Has active severe GI disorders
Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3 months prior to Enrollment Visit or serum calcium < 7 mg/dL at the Enrollment Visit
Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment
Is currently pregnant or breastfeeding
Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator's clinical judgment
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| Name | Affiliation | Role |
|---|---|---|
| Mai-Szu Wu, M.D. | Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35239732 | Derived | Lee CT, Lee CC, Wu MJ, Chiu YW, Leu JG, Wu MS, Peng YS, Wu MS, Tarng DC. Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial. PLoS One. 2022 Mar 3;17(3):e0264727. doi: 10.1371/journal.pone.0264727. eCollection 2022. |
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| 13 months |
| Ferritin | Time-course changes of ferritin from baseline. | 13 months |
| Transferring saturation (TSAT) percentage | Time-course changes of transferring saturation (TSAT) percentage from baseline. | 13 months |
| Serum iron | Time-course changes of serum iron from baseline. | 13 months |
| Total iron-binding capacity (TIBC) | Time-course changes of total iron-binding capacity (TIBC) from baseline. | 13 months |
| Hemoglobin | Time-course changes of hemoglobin from baseline. | 13 months |
| Dose of IV iron | Time-course changes of dose of IV iron from baseline. | 13 months |
| Dose of erythropoiesis stimulating agents (ESA) | Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline. | 13 months |
| Treatment adherence | Prescribed dose and the dose actually taken at each time point will be calculated. | 13 months |
| Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital | Keelung | 20401 | Taiwan |
| Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital | New Taipei City | 22060 | Taiwan |
| Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital | Taipei | 11042 | Taiwan |
| Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 11101 | Taiwan |
| Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D010760 | Phosphorus Metabolism Disorders |
| D054559 | Hyperphosphatemia |
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D008659 | Metabolic Diseases |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| 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 |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C025314 | ferric citrate |
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