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Sponsors and Collaborators: |
Wyeth 3Eff S.A. |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00697112 |
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 of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppresive treatment with sirolimus.
Condition |
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Renal Transplant |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Surveillance Registry of Sirolimus (Srl) Use in Recipients of Kidney Allograft From Expanded Criteria Donors (Ecd |
Estimated Enrollment: | 100 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Observational, sirolimus open label one arm study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Kidney allograft recipients
Inclusion Criteria:
Exclusion Criteria:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Argentina | |
Recruiting | |
Santa Fé, Argentina, 3000 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 102385 |
Study First Received: | June 10, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00697112 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
REGISTRY KIDNEY ALLOGRAFT SIROLIMUS |
Sirolimus Clotrimazole Miconazole Tioconazole |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |