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

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ClinicalTrials.gov Identifier: NCT02268994
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : February 21, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Brief Summary:
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").

Condition or disease Intervention/treatment Phase
Anemia of Chronic Kidney Disease Drug: ferric citrate Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: KRX-0502

Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.



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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:

  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

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): NCT02268994


  Show 36 Study Locations
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
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

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02268994     History of Changes
Other Study ID Numbers: KRX-0502-306
First Posted: October 20, 2014    Key Record Dates
Results First Posted: February 21, 2018
Last Update Posted: March 22, 2018
Last Verified: February 2018

Keywords provided by Keryx Biopharmaceuticals:
ferric citrate
Chronic kidney disease
Anemia

Additional relevant MeSH terms:
Citric Acid
Ferric Compounds
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics