Graft Failure Clinical Trial
Official title:
Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study
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.
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:
1. 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.
2. Serious adverse events (as internationally defined by ICH-GCP) every year, for five
years.
3. Biopsy proven acute rejection rated every year, for five years.
4. 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.
5. 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.
6. Left Ventricular Mass (LVM) and Left Ventricle Ejection Fraction (LVEF) measured by
echocardiography at the end of the first year.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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