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

NCT02128074 | Completed Phase 2 Results

• 1 other identifier: KRX-0502-207
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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).

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin From Baseline to the End of 8-week Treatment Period

  8 weeks

Study Arms (1)

KRX-0502

EXPERIMENTAL

KRX-0502 (ferric citrate)

Drug: KRX-0502

Interventions

KRX-0502 DRUG

1g tablets of KRX-0502

Also known as: ferric citrate

KRX-0502

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keryx Biopharmaceuticals: lead

Study Sites (3)

Barzilai Medical Center

Ashkelon, Israel

Location

Western Galilee Hospital

Nahariya, Israel

Location

Nazareth Hospital- EMMS

Nazareth, Israel

Location

MeSH Terms

Interventions

ferric citrate

Results Point of Contact

• Title: Keryx Medical Information
• Organization: Keryx Biopharmaceuticals, Inc

medicalinfo@keryx.com

1-844-44-KERYX (844-445-3799)

Study Officials

• Yoram Yagil, MD

  The Barzilai Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 1, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 24, 2018
• Results First Posted: August 24, 2018

Record last verified: 2017-11

Locations

IL (3)