Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
NCT ID: NCT01802268
Last Updated: 2013-03-01
Study Results
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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COMPLETED
PHASE4
320 participants
INTERVENTIONAL
2008-02-29
2012-10-31
Brief Summary
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This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sirolimus
Conversion from Tacrolimus to Sirolimus
Conversion from Tacrolimus to Sirolimus
Tacrolimus
Maintenance on tacrolimus
Maintenance on tacrolimus
Interventions
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Conversion from Tacrolimus to Sirolimus
Maintenance on tacrolimus
Eligibility Criteria
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Inclusion Criteria
* recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
* patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
* all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.
Exclusion Criteria
* patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
* patients with previous history of malignancy,
* patients with significant hematological or metabolic laboratorial abnormalities.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Helio Tedesco Silva Junior
OTHER
Responsible Party
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Helio Tedesco Silva Junior
PhD
Principal Investigators
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Helio T. Silva Junior, PhD
Role: PRINCIPAL_INVESTIGATOR
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Claudia R. Felipe, PhD
Role: STUDY_CHAIR
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Valter D. Garcia, PhD
Role: STUDY_CHAIR
Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
Elias D. Neto, PhD
Role: STUDY_CHAIR
Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
Mario A. Filho, PhD
Role: STUDY_CHAIR
Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
Fabiana LC Cortieri, PhD
Role: STUDY_CHAIR
Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
Deise BM Carvalho, PhD
Role: STUDY_CHAIR
Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
Jose OM Pestana, PhD
Role: STUDY_DIRECTOR
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Locations
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Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
Curitiba, Paraná, Brazil
Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
São Jose Do Rio Preto, São Paulo, Brazil
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
São Paulo, São Paulo, Brazil
Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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0468E8-3328
Identifier Type: -
Identifier Source: org_study_id
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