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A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects with Chronic Kidney Disease Not R

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Trial Conditions
  • Anemia of Chronic Kidney Disease Stages 3 & 4
What is the purpose of this trial?

We are one of approximately 40 clinics in the United States conducting a Phase 2 study of a novel investigational drug being developed to treat anemia in patients with renal disease who are not yet on dialysis. As you know, patients with chronic kidney disease are usually treated with an injectable erythropoietin, with or without parenteral iron. The drug we are studying (FG-4592) is an oral drug that stimulates endogenous production of erythropoietin. It also has the potential to facilitate iron absorption and metabolism. The drug works by inhibiting the degradation of the hypoxia inducible factor (HIF), a transcription factor involved in coordinating endogenous response to hypoxic conditions by increasing expression of the erythropoietin gene and other means. The Sponsor of the study is FibroGen, Inc (www.fibrogen.com), located in San Francisco. We are looking for patients with Stage 3 and 4 chronic kidney disease - GFR 15 – 60 cc/min or serum creatinine in the ~1.5 – 3.0 g/dL range with hemoglobin levels under 11 g/dL who might be interested in participating in a research study. The investigational treatment (FG-4592 or placebo) is given for 4 weeks.

Date & Status

Recruiting

EligibilityDiagnosis and Main Eligibility Criteria: • CKD Stage 3 or 4 • Mean of three screening hemoglobin values ≤11.0 g/dL and all three values within 1 g/dL of each other • Serum transferrin saturation >20%, serum ferritin >100 ng/mL, and normal vitamin B-12 and folate levels • No ESA or IV iron for 60 days prior to study drug treatment • No RBC transfusion or androgen treatment for 12 weeks prior to study drug treatment • No LFT abnormalities, history of liver disease, or excessive alcohol consumption, defined as three or more alcoholcontaining drinks per day • Not hepatitis C virus (HCV) antibody positive (Ab+), HBsAg+, or positive for human immunodeficiency virus (HIV+) • Negative fecal occult blood test and no history of hemolysis • No PKD, inflammatory diseases, active infections, history of most malignancies, bone marrow fibrosis, recent myocardial infarction or acute coronary syndrome, or New York Heart Association Class III or IV congestive heart failure • No thromboembolic events within 4 weeks of treatment • Not anticipated to require certain drugs that are primarily metabolized by CYP2C8, dapsone, or acetaminophen >2.6 g/day
Steward Physician(s)
Facilities
  • St. Elizabeth's Medical Center - Recruiting
For more information about this trial, contact

Karen Rider, RN
karen.rider@steward.org
Phone: 617-789-5136


Physician Researcher

Physician Name/s:

  • James A. Strom MD
  • Other Information

    Sponsor: Fibrogen, Inc
    Phase: Phase 2
    Trial ID: FGCL-SM4592-017
    Volunteers:  Not Accepting Healthy Volunteers

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