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

NCT ID: NCT02128074

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-11-30

Brief Summary

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).

Detailed 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).

Conditions

Anemia of Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KRX-0502

KRX-0502 (ferric citrate)

Group Type: EXPERIMENTAL

KRX-0502

Intervention Type: DRUG

1g tablets of KRX-0502

Interventions

KRX-0502

1g tablets of KRX-0502

Intervention Type: DRUG

Other Intervention Names

ferric citrate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keryx Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoram Yagil, MD

Role: STUDY_CHAIR

The Barzilai Medical Center

Locations

Barzilai Medical Center

Ashkelon, , Israel

Western Galilee Hospital

Nahariya, , Israel

Nazareth Hospital- EMMS

Nazareth, , Israel

Countries

Israel

Other Identifiers

KRX-0502-207

Identifier Type: -

Identifier Source: org_study_id