A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

June 2, 2016 updated by: Keryx Biopharmaceuticals

A Long-Term Safety Extension Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis

A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Rio Piedras, Puerto Rico
        • RCMI-Clinical Research Center
  • United States
    • California
      • Los Angeles, California, United States, 90073
        • Veterans Administration Greater Los Angeles Health Care System
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Westminster, Colorado, United States, 80031
        • Western Nephrology and Metabolic Bone Disease, PC
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Kidney Care Associates, LLC
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Circle Medical Management
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • DaVita Dialysis Unit 494/Nephrology Specialists, PC
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Dept of Internal Medicine, Nephrology & Hypertension
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Washington Nephrology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Springfield, Massachusetts, United States, 01107
        • Western New England Renal & Transplant Associates, Pc
    • Michigan
      • Dearborn,, Michigan, United States, 48124
        • Nephrology Hypertension Clinic, PC
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Pontiac, Michigan, United States, 48341
        • Rochester Hills DaVita Dialysis
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Kidney Center
      • Charlotte, North Carolina, United States, 28207
        • Metrolina Nephrology Associates, PA
      • Durham, North Carolina, United States, 27705
        • Duke University Dept of Medicine/Nephrology
      • Winston-Salem, North Carolina, United States, 27101
        • Piedmont Dialysis Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Clinical Research Limited
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Southeast Renal Research Institute Nephrology Associates
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205
        • Nephrology Associates, PC
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Kidney Associates, PLLC
      • Houston, Texas, United States, 77030
        • Med Center Dialysis
      • Houston, Texas, United States, 77384
        • Kidney Specialists of North Houston, PLLC
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont/ Fletcher Allen Health Care: Renal Services
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Nephrology Clinical Research Center
      • Fairfax, Virginia, United States, 22030
        • Clinical Research & Consulting Center, LLC
      • Fairfax, Virginia, United States, 22033
        • Nephrology Associates of Northern Virginia, Inc.
      • Hampton, Virginia, United States, 23666
        • Butler Farms Dialysis
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304
  2. Willing and able to give informed consent

Exclusion Criteria:

  1. Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
  2. Any subject in Study KRX-0502-304 SAP who early terminated from the trial
  3. Any subject who participated in Study KRX-0502-304 but declined EAP
  4. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  5. History of malignancy in the last five years
  6. Previous intolerance to KRX-0502 (ferric citrate)
  7. Intolerance to oral iron-containing products
  8. Absolute requirement for oral iron therapy
  9. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
  10. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
  11. Inability to tolerate oral drug intake
  12. Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
  13. Inability to cooperate with study personnel or history of noncompliance
  14. Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Ferric Citrate
Open label extension of those completing study KRX-0304
Drug: ferric citrate
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Other Names:
  • Auryxia
  • KRX-0502

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Parameters
Time Frame: 48 Weeks
Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).
48 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Phosphorus- Baseline
Time Frame: Baseline
Baseline
Serum Phosphorus- Week 48
Time Frame: 48 weeks
48 weeks
Ferritin- Baseline
Time Frame: Baseline
Baseline
Ferritin- Week 48
Time Frame: 48 weeks
48 weeks
Transferrin Saturation (TSAT) - Baseline
Time Frame: Baseline
Baseline
TSAT- Week 48
Time Frame: 48 weeks
48 weeks
Hemoglobin- Baseline
Time Frame: Baseline
Baseline
Hemoglobin- Week 48
Time Frame: 48 weeks
48 weeks
IV Iron Use
Time Frame: 48 weeks
Percent of subjects with No IV iron intake from first dose of study drug to Week 48
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Keryx Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KRX-0502-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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