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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00117065 |
The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.
Condition | Intervention | Phase |
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Anemia |
Drug: Aranesp® |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Study of Transplant Related Anemia Treated With Aranesp® (STRATA) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030139 |
Study First Received: | June 30, 2005 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00117065 History of Changes |
Health Authority: | United States: Institutional Review Board |
Kidney transplant, Renal transplant Aranesp®, Darbepoetin alfa Amgen, Q2W dosing, Q4W dosing |
Hematinics Hematologic Diseases Darbepoetin alfa Anemia |
Hematinics Hematologic Diseases Therapeutic Uses Hematologic Agents |
Darbepoetin alfa Anemia Pharmacologic Actions |