Renal Transplantation in the Elderly - nEverOld Study

NCT01631058 | Unknown Phase 4 DMC

• 1 other identifier: 26423
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Renal Failure (CRF); Graft Failure; Transplant; Failure, Kidney; Renal Transplant Rejection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of functional graft

  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.

  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.

Secondary Outcomes (12)

• Pharmacokinetic of Tacrolimus

  Days: 7, 30, 60, 67, 90, 180.

• Serious adverse events

  Every year, for five years

• Biopsy

  Every year, for five years

• Renal filtration markers

  Days: 7, 30, 37, 60, 67, 90, 180. Months: 12, 18, 24, 36, 48, 60

• Bone density

  Month 12

Study Arms (1)

Everolimus

EXPERIMENTAL

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

Interventions

Everolimus DRUG

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.

Also known as: Certican (NOVARTIS), Myfortic (NOVARTIS), Prednisone (generic)

Everolimus

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• Allergy to any of proposed medications
• Patients with any active infection including HBV, HCV and HIV.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Clinical Hospital of the School of Medicine, University of Sao Paulo

São Paulo, São Paulo, 05403900, Brazil

RECRUITING

Clinical Hospital of the School of Medicine, University of Sao Paulo

São Paulo, São Paulo, 05403900, Brazil

RECRUITING

Related Publications (1)

• Romano P, Agena F, de Almeida Rezende Ebner P, Massakazu Sumita N, Kamada Triboni AH, Ramos F, Dos Santos Garcia M, Coelho Duarte NJ, Brambate Carvalhinho Lemos F, Zocoler Galante N, David-Neto E. Longitudinal Pharmacokinetics of Mycophenolic Acid in Elderly Renal Transplant Recipients Compared to a Younger Control Group: Data from the nEverOld Trial. Eur J Drug Metab Pharmacokinet. 2019 Apr;44(2):189-199. doi: 10.1007/s13318-018-0506-6.

  PMID: 30229398 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Everolimus; lactitol; Mycophenolic Acid; Prednisone; Drugs, Generic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pharmaceutical Preparations

Study Officials

• Elias David-Neto, PhD

  Clinical Hospital of the School of Medicine, University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias David-Neto, PhD

CONTACT

+55 11 26618089; elias@cntt.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 28, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: June 1, 2019
• Last Updated: December 4, 2015

Record last verified: 2013-01

Locations

BR (2)