Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 Real World Experience Study from Kaiser Permanente Southern California

Detailed Description
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PROTOCOL SUMMARY Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 Real World Experience Study from Kaiser Permanente Southern California Short Title: FeCitrate Protocol Number: KP FeCitrate Study Phase: 4 Study Site(s): Los Angeles Kaiser Sunset Medical Center Number of Subjects: 55 Study Arms: 1 Indication: Hyperphosphatemia in end stage renal disease Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a real world environment Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months). Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (<5.5mg/dl) 6 months before and after treatment with ferric citrate Statistical Methods: Not powered to detect statistical significance

Official Title
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Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 Real World Experience Study From Kaiser Permanente Southern California

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: Ferric Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment No allergy to iron Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment Mean PTH < 1000 pg/ml for 6 months prior to enrollment Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment Exclusion Criteria: History of gastrointestinal bleeding within past 6 months History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months Acute kidney injury equal to or less than 3 months before the initial screening date Active malignancy Functioning renal transplant Patients with iron overload syndrome (e.g., Hemochromatosis) History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease Active or past history of calciphylaxis
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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ferric Citrate<br>Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. | Drug: Ferric Citrate<br>* One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.<br>* Other names: Auryxia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phosphorus Levels | Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravenous (IV) Iron | The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment. | 6 months | 
| Erythropoiesis Stimulating Agents (ESA) Dose | Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome. | 6 months | 
| Median Pill Count | median pill count of ferric citrate pills/day required to maintain phosphorus control | 6 months |