Status:
COMPLETED
KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
Lead Sponsor:
Keryx Biopharmaceuticals
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 per...
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 per...
Eligibility Criteria
Inclusion
- Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
- Age ≥18 years
- 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)
- Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)
- Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening
- Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening
- Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening
- Must consume a minimum of 2 meals per day
- Willing and able to give written informed consent
Exclusion
- Serum phosphate \<3.5 mg/dL at Screening
- Liver enzymes (ALT/AST) \>X3 times upper limit of normal at Screening
- Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
- Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
- Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening
- 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
- Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)
- History of hemochromatosis
- 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)
- Subjects with known allergic reaction to previous oral iron therapy
- 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 (anticipated to last \>72 hours) during the randomized period of the trial other than dialysis access related surgery.
- 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
- Inability to cooperate with study personnel
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT02268994
Start Date
October 1 2014
End Date
January 1 2016
Last Update
March 22 2018
Active Locations (36)
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1
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States, 85027
2
Southwest Kidney Institute
Tempe, Arizona, United States, 85284
3
California Renal Research
Glendale, California, United States, 91204
4
Southern California Medical Research Center
La Palma, California, United States, 90623