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Eligibility
for people ages 18–130
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis.

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Details

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic patients with Stage 3, 4 or 5 chronic kidney disease (CKD) who are not on dialysis.

Keywords

Anemia Renal, CKD, Roxadustat, anemia, non-dialysis

Eligibility

You can join if…

Open to people ages 18–130

  • A glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, corresponding to stage 3, 4 or 5 chronic kidney disease (CKD) according to the Kidney Disease Outcomes Quality Initiative, not receiving dialysis.
  • Mean of 2 most recent central laboratory hemoglobin (Hb) values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL.- Ferritin ≥50 ng/mL at randomization.
  • Transferrin saturation ≥15% at randomization.
  • Serum folate level ≥ lower limit of normal (LLN) at randomization. - Serum vitamin B12 level ≥LLN at randomization.
  • Alanine aminotransferase and aspartate aminotransferase ≤3 x upper limit of normal(ULN) and total bilirubin ≤1.5 x ULN at randomization.
  • Body weight 45 to 160 kg.

You CAN'T join if...

  • Any erythropoietin analogue treatment within 6 weeks of randomization.
  • New York Heart Association Class III or IV congestive heart failure at enrollment- Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism)within 12 weeks prior to randomization.
  • History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver).
  • Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD.
  • Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis).
  • Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category II F, III or IV)of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g.computerized tomography scan or magnetic resonance imaging conducted at screening or within 12 weeks prior to randomization.
  • Systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may be rescreened once BP controlled.
  • History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
  • Positive for any of the following: human immunodeficiency virus, hepatitis B surface antigen or anti-hepatitis C virus antibody.
  • Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia.
  • Known hemosiderosis, hemochromatosis or hypercoagulable condition.
  • Any prior organ transplant or a scheduled organ transplantation date.
  • Any red blood cell transfusion during the screening period.
  • Any current condition leading to active significant blood loss.
  • Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor.
  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of investigation product in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded).
  • History of alcohol or drug abuse within 2 years prior to randomization.
  • Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
  • Pregnant or breastfeeding females.
  • Known allergy to the investigational product or any of its ingredients.
  • Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment or may interfere with study participation.

Locations

  • Research Site
    San Francisco, California, United States
  • Research Site
    Sacramento, California, United States
  • Research Site
    Bakersfield, California, United States
  • Research Site
    San Luis Obispo, California, United States
  • Research Site
    Northridge, California, United States
  • Research Site
    Reno, Nevada, United States
  • Research Site
    Glendale, California, United States
  • Research Site
    Los Angeles, California, United States
  • Research Site
    Lynwood, California, United States
  • Research Site
    San Dimas, California, United States
  • Research Site
    Upland, California, United States
  • Research Site
    Long Beach, California, United States
  • Research Site
    Orange, California, United States
  • Research Site
    Las Vegas, Nevada, United States
  • Research Site
    Escondido, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT02174627
Phase
Phase 3
Lead Scientist
Sam James
Study Type
Interventional
Last Updated
April 1, 2017