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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helio Tedesco Silva Junior
• Collaborator: Pfizer
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• patients older than 18 years,

• 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 chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,

• 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.