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RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients
Sponsor: University Medical Center Groningen
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
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
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