Status:
COMPLETED
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
Lead Sponsor:
Pfizer
Conditions:
Renal Transplantation
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions ...
Detailed Description
pilot study
Eligibility Criteria
Inclusion
- Patients aged 18 years or older.
- Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year at the time of study enrollment.
- Patients who provided informed consent.
- Patients without sirolimus as base therapy.
Exclusion
- Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf.
- Patients who are unable to complete the study.
- Patients who are participating in another clinical trial during the last 6 months.
- Pregnant or lactating patients.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00697112
Start Date
May 1 2008
End Date
December 1 2012
Last Update
January 22 2014
Active Locations (8)
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1
Pfizer Investigational Site
Caba, Buenos Aires, Argentina, 1425
2
Pfizer Investigational Site
Caba, Buenos Aires, Argentina, C1093AAS
3
Pfizer Investigational Site
Caba, Buenos Aires, Argentina, C1181ACH
4
Pfizer Investigational Site
Caba, Buenos Aires, Argentina