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

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

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

A total of 28 Hemodialysis (HD) patients were enrolled. Of these, 2 patients withdrew prior to receiving the study drug, 3 patients withdrew within the first 2 weeks due to adverse event, 2 patients withdrew themselves after 1 day. Only 1 of the 27 Peritoneal Dialysis (PD) patients enrolled in the study withdrew.

7 months

Adverse event (AE's) were included for all patient who received study drug for at least 1 day (n=54). After the baseline visit adverse events are collected on a weekly basis for the hemodialysis patients, and on a bi-monthly basis from the dialysis patients, and again 30days after the termination of the study.