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AstraZeneca

AstraZeneca Clinical Research Study

To apply for this study or to find out more information, come into our main office or contact:

      Melissa Bartel 
  Research Coordinator
     (210) 445-0798
        Main Office
      315 N San Saba
San Antonio, TX, 78207
Compensation may be provided for time and travel 
Duration: 2 year study
Description: A phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluation for the safety and efficiency of Roxadustat for the treatment of Anemia in Chronic Disease patients not on dialysis.

Each patient should meet all of the inclusion and exclusion criteria for  this study. Under no circumstances can there be exceptions to this rule.

Inclusion Criteria

By meeting these, you can qualify for the study.

  1. Provision of informed consent that will be signed prior to any study procedures.
  2. Greater than 18 years of age.
  3. eGFR <60 mL/min/1.73 m2, calculated by central lab, corresponding to stage 3, 4, or 5 of Chronic Kidney Disease. NOT receiving dialysis.
  4. Body weight 45 (~99 lbs) to 160 kg (~353 lbs).

These requirements will be decided if met at the Screening Visit:

  1. Average of 2 most recent central lab Hb values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL.
  2. Ferritin >50 ng/mL at randomization.
  3. TSAT >15% at randomization.
  4. Sreum folate level > lower limit of normal (LNN) at randomization.
  5. Sreum vitamin B12 level > LLN at randomization.
  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3 x upper limit of normal (ULN) and total bilirubin (Tbili) <1.5 x ULN at randomization

Exclusion Criteria

If you meet any of these, you cannot qualify for the study.                    

  1. Involvement in the planning and/or conduct of this study.
  2. Previous randomization in this study.
  3. Any erythropoietin analogue treatment within 6 weeks of randomization
  4. New York Heart Association Class III or IV congestive heart failure at enrollment.
  5. Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
  6. History of chronic liver disease (e.g. chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis or fibrosis of the liver.
  7. 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 Chronic Kidney Disease.
  8. Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis).
  9. Diagnosis or suspicion (e.g complex kidney cysts of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. .CT scan or MRI) conducted at screening or within 12 weeks prior to randomization.
  10. Systolic BP >160 mmHg or diastolic BP >95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be re-screened once BP controlled.
  11. 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.
  12. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab).
  13. Chronic inflammatory diseases such as rheumatoid arthritis, SLE, ankylosing, spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principle cost of anemia.
  14. Known hemosiderosis, hemochromatosis, or hypercoagulable condition.
  15. Any prior organ transplant or a scheduled organ transplant date.
  16. Any red blood cell transfusion (RBC) during the screening period.
  17. Any current condition leading to active significant blood loss.
  18. Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
  19. 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 one month of the first administration of IP in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded).
  20. History of alcohol or drug abuse within 2 years prior to this randomization.
  21. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
  22. Pregnant or breastfeeding females.
  23. Known allergy to the investigational product or any of its ingredients.
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