Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

NCT03079869 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: FeCitrate11035
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intravenous (IV) Iron

  6 months

• Erythropoiesis Stimulating Agents (ESA) Dose

  6 months

• Median Pill Count

  6 months

Study Arms (1)

Ferric Citrate

OTHER

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

Interventions

Ferric Citrate DRUG

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

Also known as: Auryxia

Ferric Citrate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Keryx Biopharmaceuticals: collaborator

Study Sites (1)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: KPSC PRS Administrator
• Organization: Kaiser Permanente

RE-CTCAT@kp.org

626-720-7463

Study Officials

• Victoria Kumar, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 15, 2017
• Study Start: May 1, 2017
• Primary Completion: September 14, 2019
• Study Completion: September 14, 2019
• Last Updated: January 13, 2022
• Results First Posted: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)