KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD

February 22, 2018 updated by: Keryx Biopharmaceuticals

A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia (IDA) in Adult Subjects With Non-Dialysis Dependent (NDD) Chronic Kidney Disease

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").

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

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline

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.
234

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • AKDHC Medical Research Services, LLC
      • Tempe, Arizona, United States, 85284
        • Southwest Kidney Institute
    • California
      • Glendale, California, United States, 91204
        • California Renal Research
      • La Palma, California, United States, 90623
        • Southern California Medical Research Center
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute, Inc
      • Riverside, California, United States, 92505
        • Apex Research of Riverside
      • Sacramento, California, United States, 95825
        • Capital Nephrology Medical Group
      • San Diego, California, United States, 92123
        • California Institute of Renal Research
      • San Diego, California, United States, 92103
        • La Jolla Clinical Research, Inc
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Nephrology
    • Florida
      • DeLand, Florida, United States, 32123
        • Creekside Medical Research
      • Edgewater, Florida, United States, 32132
        • Riverside Clinical Research
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research, Inc
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Kidney Care Associates, LLC
      • Macon, Georgia, United States, 31217
        • Renal Physicians of Georgia, PC
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Pacific Renal Research Institute
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Advanced Renal Care
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Kansas Nephrology Research Institute
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Renal Associates of Baton Rouge
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Western new England Renal & Transplant Associates
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Renaissance Renal Research
      • Pontiac, Michigan, United States, 48341
        • Michigan Kidney Consultants, PC
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Clinical Research Consultants
    • Nebraska
      • Lincoln, Nebraska, United States, 68105
        • Lincoln Nephrology & Hypertension
    • Nevada
      • Reno, Nevada, United States, 89519
        • Sierra Nevada Nephrology Asoociates
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mountain Kidney & Hypertension Associates
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Nephrology
    • Texas
      • Austin, Texas, United States, 78758
        • Research Management, Inc.
      • Austin, Texas, United States, 78732
        • Research Management, Inc
      • Lufkin, Texas, United States, 75904
        • TAD Clinical Research
      • San Antonio, Texas, United States, 78229
        • San Antonio Kidney Disease Center
      • San Antonio, Texas, United States, 78215
        • Clinical Advancement Center
      • San Antonio, Texas, United States, 78207
        • Kidney & Hypertension Specialists
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Mendez Center for Clinical Research
      • Fairfax, Virginia, United States, 22033
        • Nephrology Associates of Northern VA, Inc.
      • Hampton, Virginia, United States, 23666
        • Peninsula Kidney Associates

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. Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
  2. Age ≥18 years
  3. CKD with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR <15 mL/min)
  4. Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)
  5. Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening
  6. Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening
  7. Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening
  8. Must consume a minimum of 2 meals per day
  9. Willing and able to give written informed consent

Exclusion Criteria:

  1. Serum phosphate <3.5 mg/dL at Screening
  2. Liver enzymes (ALT/AST) >X3 times upper limit of normal at Screening
  3. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
  4. Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
  5. Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening
  6. IV iron administered within 4 weeks prior to Screening
  7. Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening
  8. Blood transfusion within 4 weeks prior to Screening
  9. Receipt of any investigational drug within 4 weeks prior to Screening
  10. Cause of anemia other than iron deficiency or chronic kidney disease
  11. Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)
  12. History of hemochromatosis
  13. Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)
  14. Subjects with known allergic reaction to previous oral iron therapy
  15. Previous intolerance to oral ferric citrate
  16. Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
  17. Planned surgery or hospitalization (anticipated to last >72 hours) during the randomized period of the trial other than dialysis access related surgery.
  18. Any other medical condition that, in the opinion of the PI, renders 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
  19. Inability to cooperate with study personnel

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching placebo
Experimental: KRX-0502 (ferric citrate)
1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
Drug: ferric citrate
1 g ferric citrate containing approximately 210 mg of ferric iron
Other Names:
  • 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
Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period
Time Frame: Week 16
Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline
Time Frame: Baseline and week 16
The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.
Baseline and week 16
Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline
Time Frame: Baseline and week 16
The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.
Baseline and week 16
Mean Change in Ferritin at the End of 16 Weeks Minus Baseline
Time Frame: Baseline and week 16
The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.
Baseline and week 16
Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)
Time Frame: Week 16
Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period
Week 16
Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline
Time Frame: Baseline and week 16
The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.
Baseline and week 16

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Geoffrey Block, MD, Denver Nephrology
  • Study Chair: Glenn Chertow, MD, Division of Nephrology at Stanford University School of Medicine
  • Study Chair: Steven Fishbane, MD, Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center

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.
October 1, 2014

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.
January 1, 2016

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.
January 1, 2016

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).
October 11, 2014

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.
October 16, 2014

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.
October 20, 2014

Study Record Updates

Last Update Posted (Actual)

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.
March 22, 2018

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.
February 22, 2018

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.
February 1, 2018

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-0502-306

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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