Overview

Study of Transplant Related Anemia Treated With Aranesp® (STRATA)

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Darbepoetin alfa
Criteria
Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living
or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential -
Available for follow-up assessments and dosing visits - Hb concentration less than 11.0
g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the
screening period Exclusion Criteria: - Expected to initiate dialysis or transplantation or
be scheduled for a kidney transplant within 6 months of study start, or have less than 1
year life expectancy - Systemic hematologic disease, myeloma, hemolytic anemia, or
malignancy (excluding basal cell carcinoma) - Active systemic or chronic infection -
Uncontrolled hypertension defined as diastolic blood pressure greater than 110 mm Hg on 2
separate occasions during the 2 weeks prior to screening - Known hypersensitivity to
Aranesp® or any of the product's excipients - Disorders that compromise the ability of the
subject to give written informed consent and/or to comply with study procedures - Use of
any erythropoietic protein or androgen therapy within the 12 weeks prior to screening -
Females who are pregnant or breast-feeding - Currently enrolled in or received treatment in
an investigational drug/device trial within the past 30 days - Have previously been
enrolled in this study - Recent history (within 12 weeks prior to screening) of severe
cardiovascular events, grand mal seizure, dialysis or major surgery - Have received a red
blood cell transfusion(s) within 8 weeks prior to screening, or currently have active
bleeding