This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02268994
First received: October 11, 2014
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Anemia of Chronic Kidney Disease Drug: ferric citrate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 in Adult Subjects With Non-Dialysis Dependent Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Keryx Biopharmaceuticals:

Primary Outcome Measures:
  • The between group comparison of the proportion of subjects achieving an increase in Hgb of ≥1.0 g/dL at any time point between baseline and the end of the 16-week Randomized Period [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Mean change in Hgb from baseline to end of the 16-week Randomized Period [ Time Frame: 16 weeks ]
  • Mean change in TSAT from baseline to end of the 16-week Randomized Period [ Time Frame: 16 weeks ]
  • Mean change in ferritin from baseline to end of the 16-week Randomized Period [ Time Frame: 16 weeks ]
  • The difference in the proportion of subjects experiencing a sustained treatment effect on hgb [ Time Frame: 16 weeks ]
  • Mean change in serum phosphate from baseline to end of the 16-week Randomized Period [ Time Frame: 16 weeks ]

Enrollment: 234
Study Start Date: September 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRX-0502 (ferric citrate)
1 gr of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
Drug: ferric citrate
1 gr ferric citrate containing approximately 210 mg of ferric iron
Other Name: KRX-0502
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching placebo

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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 TSAT <25% at Screening
  7. Serum 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02268994     History of Changes
Other Study ID Numbers: KRX-0502-306
Study First Received: October 11, 2014
Last Updated: March 9, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017