Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe Year AfTer lIver transplantatiON (ALTERNATION)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHannover Medical School
About this trial
The overall aim of this study is nephroprotection based on a calcineurin inhibitor (CNI)-free therapy beyond year one after orthotopic liver transplantation (OLT) in highly pre-selected patients with low rejection risk.
Eligibility criteria
Qualifiers
Men**, women*, inter/diverse aged ≥ 18 or <80 years
Signed written informed consent from subject
Liver allograft recipients, either deceased or living donor liver transplant
Liver transplantation more than 12 months ago and less than 36 months ago
Disqualifiers
Previous CNI-free IS
Acute or chronic rejection within the 36 months prior to screening
Prednisolone intake due to another autoimmune disease for more than 8 weeks
eGFR <30ml/min and/or proteinuria >0.5g/l (to mitigate the risk of worsening renal failure should rejection occur and high level of CNI might be required and proteinuria as a contraindication for mTORI-based therapy)
Trial design
Treatments tested in this trial
- Everolimus
- Tacrolimus or Cyclosporine
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hannover Medical School
Lead sponsor
Royal Infirmary of Edinburgh
Collaborator
Source ClinicalTrials.gov