NCT01802268

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

Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Helio Tedesco Silva Junior · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Conversion from Tacrolimus to Sirolimus
DRUG	Maintenance on tacrolimus

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-04-01
• Completion: 2012-10-01
• First posted: 2013-03-01
• Last updated: 2013-03-01

Locations

6 sites across 1 country: Brazil