A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on R… (NCT02040584) | Clinical Trial Compass
CompletedPhase 3
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.
Spain217 participantsStarted 2013-12-20
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Recipients age 18 or over receiving a first liver transplant from a cadaver donor.
✓. Patients diagnosed with HCC must meet the Milan radiological criteria at the time of transplant (1 nodule ≤5 cm in diameter, or 2-3 nodules, all \<3 cm in diameter) - at time of patient's inclusion on the waiting list.
✓. Patients who have signed the informed consent to participate in the study.
✓. Patients who by medical criteria are capable of complying with the study regimen.
Exclusion criteria
✕. Recipients who have received multiple transplants of solid organs or pancreatic islet cells.
✕. Patients who have previously received an organ or tissue transplant.
✕. Patients with a combined liver-kidney transplant.
✕. Recipients of lobes or segments of liver from a live donor.
✕. A history of malignancy of any organ system in the previous 3 years according to local protocols (regardless of signs of local recurrence or metastasis), other than non-metastasising basal cell carcinoma or squamous cell carcinoma (epidermoid carcinoma) of the skin, or HCC.
✕. Patients with known hypersensitivity to the drugs used in the study or others of their class, or to any of their excipients.
✕. Recipients of ABO-incompatible transplants.
What they're measuring
1
Percentages of Participants Showing Clinical Benefit by Renal Function Stratification