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

Associação Médico Espírita de Botucatu

Status and phase: Completed; Phase 4

Conditions: Disorder Related to Renal Transplantation; Cytomegalovirus Infections

Treatments: Drug: mycophenolate; Drug: Basiliximab; Drug: Thymoglobulin; Drug: Prednisone; Drug: tacrolimus; Drug: sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02683291

16966913.6.0000.5411

Details and patient eligibility

About

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.

Full description

Study Design

This will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (CMV) infection.

Treatments

In the control group (Tacrolimus + Mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug.

In the treatment group (Tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period).

In all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). Induction therapy consisted of basiliximab or antithymocyte globulin (Thymoglobulin, Genzyme®). Thymoglobulin will be used in patients with panel reactivity class I greater than 50 % (at a dose of 1mg/kg for 5 days).

Enrollment: 48 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Tacrolimus + Mycophenolate

Active Comparator group

Description:

The investigators wil be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 %

Treatment:

Drug: Thymoglobulin

Drug: Prednisone

Drug: tacrolimus

Drug: Basiliximab

Drug: mycophenolate

Tacrolimus + Sirolimus

Experimental group

Description:

The investigators will be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 %

Treatment:

Drug: sirolimus

Drug: Thymoglobulin

Drug: Prednisone

Drug: tacrolimus

Drug: Basiliximab