Disorder Related to Renal Transplantation, Cytomegalovirus Infections
Conditions
Keywords
Kidney transplantation, sirolimus, cytomegalovirus, aged
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).
Interventions
DRUGsirolimus
DRUGtacrolimus
DRUGmycophenolate
DRUGPrednisone
Prednisone 30mg/day
DRUGBasiliximab
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
DRUGThymoglobulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Sponsors
Associação Médico Espírita de Botucatu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated glomerular filtration rate from baseline | Baseline, 1 month, 3 months, 6 months and 12 months | The primary end-point will be evaluated the estimated glomerular filtration rate (eGFR) over 12 months of renal transplantation. The investigators will be measure the change in eGFR during 12 month follow-up. Glomerular filtration rate will be estimated by the MDRD equation (Modification of Diet in Renal Disease). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cytomegalovirus Infection (CMV) | Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months. | The secondary end-point will be evaluated the incidence of cytomegalovirus (CMV) infection. CMV infection will be defined based on detection of CMV viral replication (CMV pp65 antigenemia more than zero) in asymptomatic patients. CMV disease will be defined based on the evidence of CMV infection with related symptoms. For the positive cases treatment will be carried out with ganciclovir 5 mg/kg/day twice daily adjusted for renal function for a minimum of 14 days. |
Outcome results
None listed