Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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 % |
Drug: tacrolimus
Other Names:
Drug: mycophenolate
Other Names:
Drug: Prednisone
Prednisone 30mg/day
Other Names:
Drug: Basiliximab
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Other Names:
Drug: Thymoglobulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Other Names:
|
| Experimental: 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 % |
Drug: sirolimus
Other Names:
Drug: tacrolimus
Other Names:
Drug: Prednisone
Prednisone 30mg/day
Other Names:
Drug: Basiliximab
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Other Names:
Drug: Thymoglobulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Associação Médico Espírita de Botucatu
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16966913.6.0000.5411