NCT03797196

RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 374 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In this study two immunosuppressive regimes will be tested; In both groups basiliximab induction will be applied. Additionally, the standard therapy consisting of prednisolone, mycophenolic acid and tacrolimus once-daily (Envarsus®), or the comparator in which mycophenolic acid will be replaced by everolimus combined with strongly reduced levels of tacrolimus once-daily (Envarsus®). When not tolerated,tacrolimus may be replaced by ciclosporin. The hypothesis is that reduced calcineurin inhibitor (CNI) exposure in combination with everolimus will lead to improved allograft function, a reduced incidence of complications and improved quality of life. This study will consist of two strata: Stratum A: Elderly recipients (≥65 years) of kidneys from elderly deceased donors (≥65 years) within the Eurotransplant Senior Program. Stratum B: Elderly recipients (≥65 years) of kidneys from living donors (all ages) or deceased donors (\<65 years). The primary endpoint will be "successful transplantation" which is defined as survival with a functioning allograft with a minimum estimated GFR of 30 ml/min per 1.73 m2 in stratum A and 45 ml/min per 1.73 m2 in stratum B, after 2 years. The study will be performed by the Dutch transplant centers and the Dutch Kidney Patient Organization (NVN) will participate.

Conditions

• Renal Transplant Recipients
• Elderly Patients
• Immunosuppression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-29
• Primary completion: 2025-06-01
• Completion: 2026-12-01
• First posted: 2019-01-09
• Last updated: 2023-05-10

Locations

7 sites across 2 countries: Belgium, Netherlands