drugset / Trial / NCT01631058

Renal Transplantation in the Elderly - nEverOld Study

NCT01631058

Phase 4 Unknown 90 enrolled University of Sao Paulo General Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-07
Primary completion
2014-07
Completion
2019-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 1 mg