Status
Enrolling
Condition
Chronic Kidney Disease (CKD)
Description
Management of anemia in CKD persons not on dialysis.
Purpose
To evaluate the incidence of red blood cell (RBC) transfusions in chronic kidney disease persons not on dialysis (ND-CKD) using either a hemoglobin (Hb)-based titration algorithm or a weight-based dose that will not be titrated (fixed dose), and to evaluate the difference in the incidence of RBC transfusions between the 2 groups..
Phase
III
Key Inclusion Criteria
- Age 18 or older
- Clinical history of advanced CKD not on dialysis
- Chronic anemia due to renal failure
- Clinically stable in the opinion of the investigator
- Written Informed Consent
- Other protocol-defined inclusion/exclusion may apply
Key Exclusion Criteria
- Systemic hematologic disease
- Current or prior malignancy within 5 years of screening, with the exception of non-melanoma skin cancers and cervical intraepithelial neoplasia
- Female subject is not willing to use highly effective methods of birth control during treatment and for 4 weeks after the end of treatment
- Subject is pregnant or breast feeding, or might become pregnant within 4 weeks after the end of treatment
- Currently receiving systemic antibiotics for treatment of an active infection
- Known HIV positive
- Currently receiving systemic immunosuppressive therapy with the exception of prednis(ol)one < 10 mg per day (or the equivalent)
- History of any organ transplant
- Currently enrolled in another interventional study
- Known neutralizing anti-erythropoietic protein antibodies
- Known sensitivity to any of the products to be administered during dosing
- Not expected to be available for protocol required study visits or procedures to the best of the subject and investigator’s knowledge
- Other protocol-defined inclusion/exclusion may apply
ClinicalTrials.gov Identifier
NCT01652872
