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Trial record 67 of 380 for:    FERRIC CATION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02128074
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Anemia of Chronic Kidney Disease Drug: KRX-0502 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KRX-0502
KRX-0502 (ferric citrate)
Drug: KRX-0502
1g tablets of KRX-0502
Other Name: ferric citrate




Primary Outcome Measures :
  1. Change in Hemoglobin From Baseline to the End of 8-week Treatment Period [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02128074


Locations
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Israel
Barzilai Medical Center
Ashkelon, Israel
Western Galilee Hospital
Nahariya, Israel
Nazareth Hospital- EMMS
Nazareth, Israel
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
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Study Chair: Yoram Yagil, MD The Barzilai Medical Center

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Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02128074     History of Changes
Other Study ID Numbers: KRX-0502-207
First Posted: May 1, 2014    Key Record Dates
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018
Last Verified: November 2017
Additional relevant MeSH terms:
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Ferric Compounds
Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics