Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

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

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

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Ferric Citrate

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

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Drug: Ferric Citrate; One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.; Other Names: Auryxia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Keryx Biopharmaceuticals
• Investigators: Principal Investigator: Victoria Kumar, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): September 14, 2019
• Study Completion (ACTUAL): September 14, 2019

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (ACTUAL): March 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: FeCitrate; 11035 (OTHER: Kaiser Permanente Southern California IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No