A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia

November 30, 2017 updated by: Keryx Biopharmaceuticals

A Phase 2 Pilot Study of KRX-0502 (Ferric Citrate) in Treating Iron-deficiency Anemia in Patients With Stage 3-5 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD)

The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients.

This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

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

  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Nahariya, Israel
        • Western Galilee Hospital
      • Nazareth, Israel
        • Nazareth Hospital- EMMS

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening
  • Age ≥ 18 years
  • Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening
  • Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening
  • eGFR <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation

Exclusion Criteria:

  • Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening
  • Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \ Screening
  • Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening
  • Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening
  • History of hemochromatosis
  • IV iron administered within 4 weeks prior to Screening
  • Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening
  • Blood transfusion within 4 weeks prior to Screening
  • Receipt of any investigational drug within 4 weeks prior to Screening
  • Cause of anemia other than iron deficiency or chronic kidney disease
  • History of malignancy in the last five years
  • Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to Screening
  • Any known allergies to iron products
  • Previous intolerance to oral ferric citrate
  • Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
  • Planned surgery or hospitalization during the trial
  • 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

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
Intervention / Treatment
Experimental: KRX-0502
KRX-0502 (ferric citrate)
Drug: KRX-0502
1g tablets of KRX-0502
Other Names:
  • ferric citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Keryx Biopharmaceuticals

Investigators

  • Study Chair: Yoram Yagil, MD, The Barzilai 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

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRX-0502-207

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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