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Trial record 30 of 36 for:    "Viral Infectious Disease" | "Everolimus"

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

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ClinicalTrials.gov Identifier: NCT02683291
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Luis Gustavo Modelli de Andrade, Associação Médico Espírita de Botucatu

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
Disorder Related to Renal Transplantation Cytomegalovirus Infections Drug: sirolimus Drug: tacrolimus Drug: mycophenolate Drug: Prednisone Drug: Basiliximab Drug: Thymoglobulin 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2016


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:
  • Prograf
  • FK506

Drug: mycophenolate
Other Names:
  • Myfortic
  • Mycophenolate Sodium

Drug: Prednisone
Prednisone 30mg/day
Other Name: Meticorten

Drug: Basiliximab
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Other Name: Simulect

Drug: Thymoglobulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Other Name: antithymocyte globulin

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:
  • Rapamycin
  • Rapamune

Drug: tacrolimus
Other Names:
  • Prograf
  • FK506

Drug: Prednisone
Prednisone 30mg/day
Other Name: Meticorten

Drug: Basiliximab
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
Other Name: Simulect

Drug: Thymoglobulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
Other Name: antithymocyte globulin




Primary Outcome Measures :
  1. Change in estimated glomerular filtration rate from baseline [ Time Frame: 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 :
  1. Incidence of cytomegalovirus Infection (CMV) [ Time Frame: 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Layout table for additonal information
Responsible Party: Luis Gustavo Modelli de Andrade, Clinical Professor PhD, Associação Médico Espírita de Botucatu
ClinicalTrials.gov Identifier: NCT02683291     History of Changes
Other Study ID Numbers: 16966913.6.0000.5411
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luis Gustavo Modelli de Andrade, Associação Médico Espírita de Botucatu:
Kidney transplantation
sirolimus
cytomegalovirus
aged
Additional relevant MeSH terms:
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DNA Virus Infections
Virus Diseases
Everolimus
Cytomegalovirus Infections
Herpesviridae Infections
Sirolimus
Mycophenolic Acid
Prednisone
Tacrolimus
Thymoglobulin
Antilymphocyte Serum
Basiliximab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents