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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aranesp®

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No