Clinical trial NCT03079869: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Official title: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperphosphatemia
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Keryx Biopharmaceuticals
First posted: 2017-03-15
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Phosphorus Levels
timeFrame: 6 months
Secondary outcomes:
measure: Intravenous (IV) Iron
timeFrame: 6 months
measure: Erythropoiesis Stimulating Agents (ESA) Dose
timeFrame: 6 months
measure: Median Pill Count
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Victoria Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: