Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

NCT ID: NCT03079869

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-09-14

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

Conditions

Hyperphosphatemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Ferric Citrate

Intervention Type: DRUG

One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Interventions

Ferric Citrate

One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Intervention Type: DRUG

Other Intervention Names

Auryxia

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keryx Biopharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

11035

Identifier Type: OTHER

Identifier Source: secondary_id

FeCitrate

Identifier Type: -

Identifier Source: org_study_id