Study design
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EnGraft is a prospective, randomised, controlled, multicentre, open-label, two-arm, parallel-group, phase IV clinical trial to assess bioavailability and practicability of Two hundred and sixty eight (268) patients at 15 LTx centres in Germany will be enrolled and randomised in a 1:1 ratio to two study arms. Patients in the test arm will be treated with Envarsus® (test) as first-line CNI in the immunosuppressive regimen. The control arm will treat patients with Advagraf™ (comparator) as first-line CNI. Trial participants will additionally receive all of the other treatments that comprise a standard, multi-drug, immunosuppressive regimen for LTx recipients, according to routine clinical practice in Germany.Since this trial compares two commercially available medications with different pharmaceutical formulations (Envarsus® tablets versus Advagraf™ capsules), simple, cost-neutral treatment blinding is not possible. The trial is being conducted as an open-label study.LTx will be performed prior to study entry, according to the local standard at participating trial centres. An optional run-in phase is available, in case patients cannot be randomised immediately after transplantation surgery (e.g. unable to swallow study medication). Patients may be enrolled up to 14 days after surgery.The day of randomisation to EnGraft is defined as trial day 0. After a 12-week controlled treatment phase, patients enter a follow-up phase of 2 years and 9 months. The final study visit is scheduled for 3 years after randomisation.The study design adheres to the principles outlined in ICH-GCP E6 (R2). All patients aged ≥ 18 years who meet the eligibility criteria and give informed consent will be allocated to the study. Those patients are supplied with patient information. For each trial participant, an authorised and delegated trial investigator must obtain written informed consent after sufficient time for reflection prior to conducting any trial-related procedures involving the subject. After consent is obtained, patients are randomised to the trial. The used patient information sheet and the informed consent are both ethically approved (Fig. Study flowchart. Showing trial phases and treatment arms