Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Kaiser Permanente

Status and phase

Completed

Phase 4

Conditions

Hyperphosphatemia

Treatments

Drug: Ferric Citrate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03079869

11035 (Registry Identifier)

FeCitrate

Details and patient eligibility

About

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

Full 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

Enrollment

55 patients

Sex

All

Volunteers

No Healthy Volunteers

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