Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Long-Term, Open-Label, Prospective Phase IV Study to Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis

Conditions
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Kidney Failure, Chronic, End-stage Renal Disease, Phosphorus Metabolism Disorders, Hyperphosphatemia

Intervention / Treatment
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* Drug: Ferric Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is ≧ 18 years of age on the day of signing informed consent or other age required by local regulation Willing and able to provide written informed consent ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician Serum ferritin <1000 ng/mL and transferrin saturation (TSAT) < 50% at the Enrollment Visit Women of child-bearing potential (WOCBP [defined as women ≤ 50 years of age with a history of amenorrhea for < 12 months prior to study entry]) who is willing to use an effective form of contraception during study participation 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric citrate<br>Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals). | Drug: Ferric Citrate<br>* Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.<br>* Other names: Nephoxil® Capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Citric Acid, Ferric Compounds, Renal Insufficiency, Anticoagulants, Calcium Chelating Agents, Chelating Agents, Sequestering Agents, Hemodialysis, Dialysis, Renal Failure, Kidney Failure, Urologic Diseases, Metabolic Disease, Kidney Diseases, Renal Insufficiency, Chronic