title: Effect of delayed CNI-based immunosuppression with Advagraf® on liver function after MELD-based liver transplantation [IMUTECT].
abstract: BACKGROUND
  MELD-based allocation for liver transplantation follows the "sickest-patient-first" strategy. The latter patients present with both, decreased immune competence and poor kidney function which is further impaired by immunosuppressants.
  
  
  METHODS
  In this prospective observational study, 50 patients with de novo low-dose standard Advagraf®-based immunosuppression consisting of Advagraf®, Mycophenolat-mofetil and Corticosteroids after liver transplantation will be evaluated. Advagraf® trough levels of 7-10 μg/l will be reached at the end of the first postoperative week. Immunostatus, infectious complications, graft and kidney function are compared between patients with a pretransplant calculated MELD-score of ≤20 and >20. Each group comprises of 25 consecutive patients. Prior to liver transplantation and on the postoperative days 1, 3 and 7, the patients' graft function (LiMAx test) will be evaluated. On the postoperative days 3, 5 and 7 the patients' immune status will be evaluated by the measurement of their monocytic HLA-DR status.Infectious complications (CMV-reactivation, wound infection, urinary tract infection, and pneumonia), graft- and kidney function will be analysed on day 0, within the first week, and 1, 3, 6, 9 and 12 months after liver transplantation.
  
  
  CONCLUSIONS
  This study was designed to assess the effect of a standard low-dose Calcineurin inhibitor-based immunosuppression regime with Advagraf® on the rate of infectious complications, graft and renal function after liver transplantation.
  
  
  BACKGROUND
  The trial is registered at "Clinical Trials" (http://www.clinicaltrials.gov), NCT01781195.
authors.forename: Susanne
authors.initials: S
authors.lastname: Richter
authors.forename: Georg
authors.initials: G
authors.lastname: Polychronidis
authors.forename: Daniel N
authors.initials: DN
authors.lastname: Gotthardt
authors.forename: Philipp
authors.initials: P
authors.lastname: Houben
authors.forename: Thomas
authors.initials: T
authors.lastname: Giese
authors.forename: Anja
authors.initials: A
authors.lastname: Sander
authors.forename: Colette
authors.initials: C
authors.lastname: Dörr-Harim
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.affiliation: Department of General, Visceral and Transplant Surgery, Heidelberg, Germany. Peter.Schemmer@med.uni-heidelberg.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Schemmer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid