A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia

Keryx Biopharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Anemia of Chronic Kidney Disease

Treatments

Drug: KRX-0502

Study type

Interventional

Funder types

Industry

Identifiers

NCT02128074

KRX-0502-207

Details and patient eligibility

About

The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).

Full description

Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients.

This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening
Age ≥ 18 years
Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening
Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening
eGFR <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation

Exclusion criteria

Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening
Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \ Screening
Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening
Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening
History of hemochromatosis
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
History of malignancy in the last five years
Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to Screening
Any known allergies to iron products
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 during the trial
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