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

Keryx Biopharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Anemia of Chronic Kidney Disease

Treatments

Drug: ferric citrate

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02268994

KRX-0502-306

Details and patient eligibility

About

Full 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

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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