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Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

NCT01802268 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2013-03-01

No results posted yet for this study

Summary

Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.

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.

Conditions

  • Kidney Transplant

Interventions

DRUG

Conversion from Tacrolimus to Sirolimus

DRUG

Maintenance on tacrolimus

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Helio Tedesco Silva Junior

    lead OTHER

Principal Investigators

  • Helio T. Silva Junior, PhD · Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  • Claudia R. Felipe, PhD · Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

  • Valter D. Garcia, PhD · Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil

  • Elias D. Neto, PhD · Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil

  • Mario A. Filho, PhD · Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil

  • Fabiana LC Cortieri, PhD · Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil

  • Deise BM Carvalho, PhD · Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil

  • Jose OM Pestana, PhD · Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-04-30
Completion
2012-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802268 on ClinicalTrials.gov