Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.

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

Details

• Lead Sponsor: Associação Médico Espírita de Botucatu
• Treatments: Antibodies, Monoclonal; Antilymphocyte Serum; Basiliximab; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

1. Patients aged more than 60 years and recipients of compatible renal transplant

Exclusion Criteria:

1. Receptors of multiple organs;

2. non-heart beating donors;

3. donors aged under 5 or over 65 years;

4. Patients with body mass index greater than 35