Trial | NCT02683291  Report issue

Title

Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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.
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).
Study Started
Jan 31
2014
Primary Completion
Jan 31
2015
Study Completion
Jan 31
2016
Last Update
Feb 17
2016
Estimate

Drug sirolimus

  • Other names: Rapamycin, Rapamune

Drug tacrolimus

  • Other names: Prograf, FK506

Drug mycophenolate

  • Other names: Myfortic, Mycophenolate Sodium

Drug Prednisone

Prednisone 30mg/day

  • Other names: Meticorten

Drug Basiliximab

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

  • Other names: Simulect

Drug Thymoglobulin

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

  • Other names: antithymocyte globulin

Tacrolimus + Mycophenolate Active Comparator

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 %

Tacrolimus + Sirolimus Experimental

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 %

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Receptors of multiple organs;
non-heart beating donors;
donors aged under 5 or over 65 years;
Patients with body mass index greater than 35
No Results Posted