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

Completed · Phase 3 · Has a placebo group

Conditions studied: Anemia of Chronic Kidney Disease

In brief

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").

Key facts

Study ID

NCT02268994

Run by

Keryx Biopharmaceuticals

People needed

234

Starts

2014-10-01

Expected to finish

2016-01-01

Last updated by the study team

2018-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AKDHC Medical Research Services, LLC — Phoenix, Arizona, United States
• Southwest Kidney Institute — Tempe, Arizona, United States
• California Renal Research — Glendale, California, United States
• Southern California Medical Research Center — La Palma, California, United States
• Academic Medical Research Institute, Inc — Los Angeles, California, United States
• Apex Research of Riverside — Riverside, California, United States
• Capital Nephrology Medical Group — Sacramento, California, United States
• La Jolla Clinical Research, Inc — San Diego, California, United States
• California Institute of Renal Research — San Diego, California, United States
• Denver Nephrology — Denver, Colorado, United States
• Creekside Medical Research — DeLand, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Pines Clinical Research, Inc — Pembroke Pines, Florida, United States
• Kidney Care Associates, LLC — Augusta, Georgia, United States
• Renal Physicians of Georgia, PC — Macon, Georgia, United States
• Pacific Renal Research Institute — Meridian, Idaho, United States
• Advanced Renal Care — Evergreen Park, Illinois, United States
• Kansas Nephrology Research Institute — Wichita, Kansas, United States
• Renal Associates of Baton Rouge — Baton Rouge, Louisiana, United States
• Western New England Renal & Transplant Associates — Springfield, Massachusetts, United States
• Renaissance Renal Research — Detroit, Michigan, United States
• Michigan Kidney Consultants, PC — Pontiac, Michigan, United States
• Clinical Research Consultants — Kansas City, Missouri, United States
• Lincoln Nephrology & Hypertension — Lincoln, Nebraska, United States
• Sierra Nevada Nephrology Asoociates — Reno, Nevada, United States

Full record on ClinicalTrials.gov

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