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

Anemia of Chronic Kidney Disease Clinical Trial

Official title:

A Phase 2 Pilot Study of KRX-0502 (Ferric Citrate) in Treating Iron-deficiency Anemia in Patients With Stage 3-5 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128074
• Other study ID #: KRX-0502-207
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2017
• Source: Keryx Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Anemia, Iron-Deficiency
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• KRX-0502
1g tablets of KRX-0502

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Western Galilee Hospital	Nahariya
Israel	Nazareth Hospital- EMMS	Nazareth

Sponsors (1)

Lead Sponsor	Collaborator
Keryx Biopharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin From Baseline to the End of 8-week Treatment Period		8 weeks