Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Phase 4

Completed

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

Detailed Description: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ferric Citrate	Ferric Citrate	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.

Primary Outcome Measures

Name	Time	Method
Phosphorus Levels	6 months	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

Secondary Outcome Measures

Name	Time	Method
Erythropoiesis Stimulating Agents (ESA) Dose	6 months	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.
Median Pill Count	6 months	median pill count of ferric citrate pills/day required to maintain phosphorus control
Intravenous (IV) Iron	6 months	The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.