End Stage Renal DiseasePhase 3NCT01554982
A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
A Phase 3 study testing ferric citrate in people with End Stage Renal Disease and Kidney Failure, run by Keryx Biopharmaceuticals at 34 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Kidney Failure, Renal Failure
- What is being tested?
- ferric citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willing and able to give informed consent
Who cannot join
- Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
- Any subject in Study KRX-0502-304 SAP who early terminated from the trial
- Any subject who participated in Study KRX-0502-304 but declined EAP
- Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- History of malignancy in the last five years
- Previous intolerance to KRX-0502 (ferric citrate)
Show all 14Show fewer
- Intolerance to oral iron-containing products
- Absolute requirement for oral iron therapy
- Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
- Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
- Inability to tolerate oral drug intake
- 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
- Inability to cooperate with study personnel or history of noncompliance
- Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States33 sites
Asheville Kidney Center
Asheville, North Carolina, 28801
Kidney Care Associates, LLC
Augusta, Georgia, 30909
University of Colorado
Aurora, Colorado, 80045
Washington Nephrology Associates
Bethesda, Maryland, 20814
Tufts Medical Center
Boston, Massachusetts, 02111
University of Vermont/ Fletcher Allen Health Care: Renal Services
Burlington, Vermont, 05401
Clinical Research Limited
Canton, Ohio, 44718
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28207
Nephrology Clinical Research Center
Charlottesville, Virginia, 22908
Southeast Renal Research Institute Nephrology Associates
Chattanooga, Tennessee, 37408
Circle Medical Management
Chicago, Illinois, 60607
University of Cincinnati
Cincinnati, Ohio, 45267
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Nephrology Hypertension Clinic, PC
Dearborn, Michigan, 48124
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Dept of Medicine/Nephrology
Durham, North Carolina, 27705
Clinical Research & Consulting Center, LLC
Fairfax, Virginia, 22030
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, 22033
Butler Farms Dialysis
Hampton, Virginia, 23666
Kidney Associates, PLLC
Houston, Texas, 77030
Med Center Dialysis
Houston, Texas, 77030
Kidney Specialists of North Houston, PLLC
Houston, Texas, 77384
Veterans Administration Greater Los Angeles Health Care System
Los Angeles, California, 90073
DaVita Dialysis Unit 494/Nephrology Specialists, PC
Michigan City, Indiana, 46360
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Nephrology Associates, PC
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Dept of Internal Medicine, Nephrology & Hypertension
New Orleans, Louisiana, 70112
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Rochester Hills DaVita Dialysis
Pontiac, Michigan, 48341
Western New England Renal & Transplant Associates, PC
Springfield, Massachusetts, 01107
Western Nephrology and Metabolic Bone Disease, PC
Westminster, Colorado, 80031
Piedmont Dialysis Center
Winston-Salem, North Carolina, 27101
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Renal Disease, Kidney Failure, Renal Failure, Hyperphosphatemia, ESRD
- Being tested
- ferric citrate
- Keywords
- Participation Limited, Long Term, Safety Extension
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric citrateDrug
Also called Auryxia, KRX-0502
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Citrate | Other | Open label extension of those completing study KRX-0304 Receives: Drug: ferric citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Parameters
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).
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia B Lewis, MD, Study chair, Collaborative Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554982
- Sponsor's protocol ID
- KRX-0502-307
- Status last verified
- Jun 2016
- First submitted
- 12 Mar 2012
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Safety Extension Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
- ClinicalTrials.gov ID
- NCT01554982
- Acronym / sponsor ID
- KRX-0502-307
- Conditions
- End Stage Renal Disease, Kidney Failure, Renal Failure, Hyperphosphatemia, ESRD
- Keywords
- Participation Limited, Long Term, Safety Extension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Keryx BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 13 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferric Citrate | Other | Drug: ferric citrateOpen label extension of those completing study KRX-0304 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- Willing and able to give informed consent
Key exclusion criteria (14 listed)
- Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
- Any subject in Study KRX-0502-304 SAP who early terminated from the trial
- Any subject who participated in Study KRX-0502-304 but declined EAP
- Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- History of malignancy in the last five years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferric citrateAlso: Auryxia, KRX-0502Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients. | Drug | Ferric Citrate |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia B Lewis, MD study chair
Collaborative Study Group
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ferric citrate in people with End Stage Renal Disease and Kidney Failure, run by Keryx Biopharmaceuticals at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Parameters (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.