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Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

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ClinicalTrials.gov Identifier: NCT03079869
Recruitment Status : Not yet recruiting
First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Keryx Biopharmaceuticals
Information provided by (Responsible Party):
Kaiser Permanente

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

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Ferric Citrate Phase 4

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  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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 Name: Auryxia




Primary Outcome Measures :
  1. Phosphorus Levels [ Time Frame: 6 months ]
    Serum phosphorus levels after treatment with ferric citrate


Secondary Outcome Measures :
  1. IV iron [ Time Frame: 6 months ]
    Number of doses of IV iron administered after treatment with ferric citrate

  2. ESA dose [ Time Frame: 6 months ]
    Mean weekly ESA dose administered 6 months after ferric citrate treatment

  3. Average pills/day [ Time Frame: 6 months ]
    Average number of ferric citrate pills/day required to maintain phosphorus control

  4. Tolerability [ Time Frame: 6 months ]
    Tolerability of ferric citrate compared to previous binder



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079869


Contacts
Contact: Linda Gozar, MPH 626-658-6493 Linda.Gozar@kp.org
Contact: Hui Xue, MD 858-694-7132 Hui.Xue@kp.org

Sponsors and Collaborators
Kaiser Permanente
Keryx Biopharmaceuticals
Investigators
Principal Investigator: Victoria Kumar, MD Kaiser Permanente Southern California

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03079869     History of Changes
Other Study ID Numbers: FeCitrate
11035 ( Other Identifier: Kaiser Permanente Southern California IRB )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Citric Acid
Ferric Compounds
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics