Renal Transplantation in the Elderly - nEverOld Study
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ClinicalTrials.gov Identifier: NCT01631058 |
Recruitment Status : Unknown
Verified January 2013 by University of Sao Paulo General Hospital.
Recruitment status was: Recruiting
First Posted : June 28, 2012
Last Update Posted : December 4, 2015
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An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low tacrolimus for the immunosuppression in renal transplantation in the elderly.
To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this population.
To evaluate whether the polymorphism of the genes that determine the expression of metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the younger population, absorption and metabolism of immunosuppressants.
To evaluate the potential minimization of immunosuppression in this population refers to how does the re-population of peripheral lymphocytes, in this age group, after the use of lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two regimes.
Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is the right to monitor renal function in elderly transplanted.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Renal Failure (CRF) Graft Failure Transplant; Failure, Kidney Renal Transplant Rejection | Drug: Everolimus | Phase 4 |
Objectives: The objective of this study is to evaluate the safety and efficacy of everolimus (EVL) combined with low dose of Tacrolimus in comparison with Mycophenolate Sodium (MPS) combined with standard dose of Tacrolimus as immunosuppressive therapy for elderly recipients of kidney transplantation.
Comparison between the two study arms of:
Primary Objective:
1. Composite efficacy failure demonstrated by graft loss and/or death with functional graft and/or GFR (Glomerular Filtration Rate determined by EDTA-Cr51) < 50 ml/min at the end of first year after transplantation and every year until the fifth year.
Secondary Objectives:
- Pharmacokinetic study of immunosuppressive drugs (Tacrolimus, Everolimus and Mycophenolate Sodium) in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.
- Serious adverse events (as internationally defined by ICH-GCP) every year, for five years.
- Biopsy proven acute rejection rated every year, for five years.
- Identify which of the renal filtration markers existing today, Cystatin C or Serum Creatinine, is more adequate to monitor renal function in elderly transplant and to develop abbreviated equations for eGFR from day 7 on.
- Evaluation of other metabolic effects (bone density at month 12 post-transplant; vitamin D at months 2 and 12 post-transplant; and gonadal function at months 1 and 12 post-transplant) and Quality of Life at months 1, 12, 18, 24, 36, 48 and 60 post-transplant in the study population.
- Left Ventricular Mass (LVM) and Left Ventricle Ejection Fraction (LVEF) measured by echocardiography at the end of the first year.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Everolimus
Number of patients: 45 Everolimus: initial dose of 1 mg BID. Doses will be adjusted in order to maintain Everolimus whole blood trough concentrations between 3-8 ng/ml. Tacrolimus: initial dose of 0.1 mg/kg/day. Doses will be adjusted in order to maintain Tacrolimus whole blood trough concentrations between 2- 4 ng/ml thereafter. Corticosteroids: as clinical practice. |
Drug: Everolimus
This is a 5-years prospective, randomized, exploratory, single-center, parallel group trial that includes renal transplanted elderly patients (≥ 60 years old) randomized between months 1 and 3 after transplantation to be maintained under MPS/TAC regimen or be switched to EVL/low-TAC. Everolimus: initial dose of 1 mg BID. Doses will be adjusted in order to maintain Everolimus whole blood trough concentrations between 3-8 ng/ml. Tacrolimus: initial dose of 0.1 mg/kg/day. Doses will be adjusted in order to maintain Tacrolimus whole blood trough concentrations between 2- 4 ng/ml thereafter. Corticosteroids: as clinical practice. Other Names:
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- Evaluation of functional graft [ Time Frame: The study is planned to analyze all patients at the end of the fifth year after transplantation. However, an interim analysis will be done at the end of each year. ]Composite efficacy failure demonstrated by graft loss and/or death with functional graft and/or GFR (Glomerular Filtration Rate determined by EDTA-Cr51) < 50 ml/min at the end of first year after transplantation and every year until the fifth year.
- Pharmacokinetic of Tacrolimus [ Time Frame: Days: 7, 30, 60, 67, 90, 180. ]Pharmacokinetic of Tacrolimus in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.
- Serious adverse events [ Time Frame: Every year, for five years ]Evaluate serious adverse events (as internationally defined by ICH-GCP).
- Biopsy [ Time Frame: Every year, for five years ]Biopsy proven acute rejection rated every year, for five years.
- Renal filtration markers [ Time Frame: Days: 7, 30, 37, 60, 67, 90, 180. Months: 12, 18, 24, 36, 48, 60 ]Identify which of the renal filtration markers existing today, Cystatin C or Serum Creatinine, is more adequate to monitor renal function in elderly transplant and to develop abbreviated equations for eGFR from day 7 on.
- Bone density [ Time Frame: Month 12 ]Evaluation of bone density at month 12 post-transplant.
- Vitamin D [ Time Frame: Months: 2, 12. ]Evaluation of vitamin D at months 2 and 12 post-transplant.
- Gonadal function [ Time Frame: Months: 1, 12. ]Evaluation of gonadal function at months 1 and 12 post-transplant.
- Quality of Life [ Time Frame: Months: 1, 12, 18, 24, 36, 48, 60. ]Evaluate Quality of Life at months 1, 12, 18, 24, 36, 48 and 60 post-transplant in the study population.
- Left Ventricular Mass (LVM) [ Time Frame: Month: 12. ]Left Ventricular Mass (LVM) measured by echocardiography at the end of the first year.
- Left Ventricle Ejection Fraction (LVEF) [ Time Frame: Month: 12. ]Left Ventricle Ejection Fraction (LVEF) measured by echocardiography at the end of the first year.
- Pharmacokinetic of Everolimus [ Time Frame: Days: 7, 30, 60, 67, 90, 180. ]Pharmacokinetic of Everolimus in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.
- Pharmacokinetic of Mycophenolate Sodium [ Time Frame: Days: 7, 30, 60, 67, 90, 180. ]Pharmacokinetic of Mycophenolate Sodium in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All renal (only) male and female recipients aged ≥ 60, years undergoing kidney transplantation from a living or deceased donor, including Expanded Criteria Donors (ECD).
- Panel Reactive Antibody (PRA) < 30%.
- Patients who consented to participate in the study by signing the informed consent form before the transplant surgery to the 1st post-operative day).
Exclusion Criteria:
- Allergy to any of proposed medications
- Patients with any active infection including HBV, HCV and HIV.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631058
Contact: Elias David-Neto, PhD | +55 11 26618089 | elias@cntt.com.br |
Brazil | |
Clinical Hospital of the School of Medicine, University of Sao Paulo | Recruiting |
Sao Paulo, SP, Brazil, 05403900 | |
Principal Investigator: Elias David-Neto, PhD | |
Sub-Investigator: Francine B. Lemos, PhD | |
Sub-Investigator: Nelson Z. Galante, PhD | |
Sub-Investigator: Fabiana Agena, MS | |
Sub-Investigator: William C Nahas, PhD | |
Sub-Investigator: Wilson Jacob-Filho, PhD | |
Sub-Investigator: Marcelo Altona, MD | |
Sub-Investigator: Daisa R David, PhD | |
Sub-Investigator: Flavio J Paula, PhD | |
Sub-Investigator: Paschoalina Romano, MS | |
Sub-Investigator: Persio AR Ebner, Biol | |
Sub-Investigator: Maria da Luz Fernandes, MS | |
Sub-Investigator: Veronica PC Coelho, PhD | |
Sub-Investigator: Venceslau A Coelho, MD | |
Sub-Investigator: Fabio Di Nizio, MD | |
Clinical Hospital of the School of Medicine, University of Sao Paulo | Recruiting |
Sao Paulo, SP, Brazil, 05403900 | |
Principal Investigator: Elias David-Neto, PhD | |
Sub-Investigator: Francine B. Lemos, PhD | |
Sub-Investigator: Nelson Z. Galante, PhD | |
Sub-Investigator: Fabiana Agena, MS |
Principal Investigator: | Elias David-Neto, PhD | Clinical Hospital of the School of Medicine, University of Sao Paulo |
Responsible Party: | University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier: | NCT01631058 |
Other Study ID Numbers: |
26423 |
First Posted: | June 28, 2012 Key Record Dates |
Last Update Posted: | December 4, 2015 |
Last Verified: | January 2013 |
kidney transplantation chronic renal failure immunosuppressive therapy elderly pharmacokinetic tacrolimus everolimus |
mycophenolate sodium serious adverse events biopsy Cystatin C metabolic effects Left Ventricular Mass (LVM) Left Ventricle Ejection Fraction |
Renal Insufficiency Kidney Failure, Chronic Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Prednisone Everolimus Lactitol Anti-Inflammatory Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Cathartics Gastrointestinal Agents |