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

NCT ID: NCT02683291

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

Brief 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.

Detailed 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).

Conditions

Disorder Related to Renal Transplantation; Cytomegalovirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tacrolimus + Mycophenolate

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 %

Group Type: ACTIVE_COMPARATOR

tacrolimus

Intervention Type: DRUG

mycophenolate

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Prednisone 30mg/day

Basiliximab

Intervention Type: DRUG

Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %

Thymoglobulin

Intervention Type: DRUG

Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %

Tacrolimus + Sirolimus

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 %

Group Type: EXPERIMENTAL

sirolimus

Intervention Type: DRUG

tacrolimus

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Prednisone 30mg/day

Basiliximab

Intervention Type: DRUG

Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %

Thymoglobulin

Intervention Type: DRUG

Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %

Interventions

sirolimus

Intervention Type: DRUG

tacrolimus

Intervention Type: DRUG

mycophenolate

Intervention Type: DRUG

Prednisone

Prednisone 30mg/day

Intervention Type: DRUG

Basiliximab

Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %

Intervention Type: DRUG

Thymoglobulin

Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %

Intervention Type: DRUG

Other Intervention Names

Rapamycin; Rapamune; Prograf; FK506; Myfortic; Mycophenolate Sodium; Meticorten; Simulect; antithymocyte globulin

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associação Médico Espírita de Botucatu

OTHER

Sponsor Role: lead

Responsible Party

Luis Gustavo Modelli de Andrade

Clinical Professor PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

16966913.6.0000.5411

Identifier Type: -

Identifier Source: org_study_id