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

NCT02683291 | Completed Phase 4 DMC

• 1 other identifier: 16966913.6.0000.5411
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Disorder Related to Renal Transplantation; Cytomegalovirus Infections

Keywords

Kidney transplantation; sirolimus; cytomegalovirus; aged

Outcome Measures

Primary Outcomes (1)

• Change in estimated glomerular filtration rate from baseline

  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).

  Baseline, 1 month, 3 months, 6 months and 12 months

Secondary Outcomes (1)

• Incidence of cytomegalovirus Infection (CMV)

  Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months.

Study Arms (2)

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 %

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

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 %

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

Interventions

sirolimus DRUG

Also known as: Rapamycin, Rapamune

Tacrolimus + Sirolimus

tacrolimus DRUG

Also known as: Prograf, FK506

Tacrolimus + Mycophenolate; Tacrolimus + Sirolimus

mycophenolate DRUG

Also known as: Myfortic, Mycophenolate Sodium

Tacrolimus + Mycophenolate

Prednisone DRUG

Prednisone 30mg/day

Also known as: Meticorten

Tacrolimus + Mycophenolate; Tacrolimus + Sirolimus

Basiliximab DRUG

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

Also known as: Simulect

Tacrolimus + Mycophenolate; Tacrolimus + Sirolimus

Thymoglobulin DRUG

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

Also known as: antithymocyte globulin

Tacrolimus + Mycophenolate; Tacrolimus + Sirolimus

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Receptors of multiple organs;
• non-heart beating donors;
• donors aged under 5 or over 65 years;
• Patients with body mass index greater than 35

Sponsors & Collaborators

• Associação Médico Espírita de Botucatu: lead

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Sirolimus; Tacrolimus; Mycophenolic Acid; Prednisone; Basiliximab; thymoglobulin; Antilymphocyte Serum

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immune Sera; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor PhD

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 17, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share