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

Study Overview
=================
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).

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)

Conditions
-----------------
Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: KRX-0502


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRX-0502<br>KRX-0502 (ferric citrate) | Drug: KRX-0502<br>* 1g tablets of KRX-0502<br>* Other names: ferric citrate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin From Baseline to the End of 8-week Treatment Period |  | 8 weeks |