drugset / Trial / NCT02040584

A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.

NCT02040584 ↗

Phase 3 Completed 217 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function compared with standard therapy with TAC-MMF.

Timeline

Start
2013-12-20
Primary completion
2016-02-10
Completion
2016-02-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Experimental Group vs Control Group; p = 0.9423; Fisher Exact NCT02040584 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 2 mg —
Comparator MMF Unknown 500 mg —
Comparator MMF Unknown 1000 mg —
Subject Tacrolimus Small molecule — —

Indications

No indication recorded.