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ACTIVE NOT RECRUITING
NCT03797196
PHASE4

RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

Open label, randomized, multicenter, intervention trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everolimus. The primary objective is to test the hypothesis that an age-adapted immunosuppressive regimen targeted at reduced immunosuppression with low calcineurin inhibitor (tacrolimus) exposure in combination with everolimus will result in improved outcome in elderly recipients of A: Kidneys from older deceased donors (\>64 years) and B: Kidneys from living donors (all ages) and younger deceased donors (\<65 years).

Official title: Open Label Multicenter Randomized Trial Comparing Standard Immunosuppression With Tacrolimus and Mycophenolate Mofetil With a Low Exposure Tacrolimus Regimen in Combination With Everolimus in de Novo Renal Transplantation in Elderly Patient

Key Details

Gender

All

Age Range

65 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

374

Start Date

2019-07-29

Completion Date

2026-12

Last Updated

2023-05-10

Healthy Volunteers

No

Interventions

DRUG

low dose tacrolimus in combination with everolimus

a low exposure Tacrolimus once-daily (Envarsus®) regimen in combination with Everolimus will be evaluated in elderly transplant recipients

DRUG

standard dose tacrolimus with mycophenolate mofetil

A standard Tacrolimus once-daily (Envarsus) regimen in combination with Everolimus will be evaluated in elderly transplant recipients

Locations (7)

Leuven University Hospital

Leuven, Belgium

Amsterdam UMC

Amsterdam, Netherlands

UMCG

Groningen, Netherlands

LUMC

Leiden, Netherlands

Radboud University Hospital

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

UMCU

Utrecht, Netherlands