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Study Evaluating Rapamune® Maintenance Regimen

Last updated on March 14, 2019

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Study Location
Deagu, , 700-712 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Age greater than or equal to 13 years of age.

2. End-stage renal disease in patients scheduled to receive a primary renal allograft
from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding
0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte
antigen (HLA) antigen not shared by the patient.

3. Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Evidence of active systemic or localized major infection at the time of initial
sirolimus administration.

2. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
pre-study screening.

3. Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac
abnormality contraindicating general anesthesia or surgery.

4. History of malignancy within 5 years before enrollment into the study (with the
exception of adequately treated basal cell or squamous cell carcinoma of the skin).

5. Current treatment with partial opioid agonists (eg, buprenorphine) or combination
agonists/antagonists.

NCT00478608
Pfizer
Completed
Study Evaluating Rapamune® Maintenance Regimen

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