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

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ClinicalTrials.gov Identifier: NCT00117065
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.

Condition or disease Intervention/treatment Phase
Anemia Drug: Aranesp® Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Transplant Related Anemia Treated With Aranesp® (STRATA)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources




Primary Outcome Measures :
  1. Hemoglobin values

Secondary Outcome Measures :
  1. SF-36 summary and individual domain scores at week 24


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117065


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00117065     History of Changes
Other Study ID Numbers: 20030139
First Posted: July 4, 2005    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Amgen:
Kidney transplant, Renal transplant
Aranesp®, Darbepoetin alfa
Amgen, Q2W dosing, Q4W dosing

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics