title: Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized, multicentre study.
abstract: Previous clinical data suggested that with a tacrolimus-based regimen adjunctive immunosuppressives may be withdrawn after an initial treatment period. This study investigated the early discontinuation of mycophenolate mofetil (MMF) from a standard triple regimen. Patients were randomized either to receive a continued tacrolimus/MMF/steroids triple regimen (control group) or to reduce and then stop the MMF dose (MMF stop group). Both groups received identical daily tacrolimus and corticosteroid doses. The initial MMF dose was 1 g/day in both arms, but in the MMF stop group the dose was reduced to 0.5 g/day from week 7 to week 12 and then stopped. The intent-to-treat population consisted of 74 (control) and 78 (MMF stop) patients. MMF was tapered off as planned in 82.9% of the patients in the MMF stop arm. The 6-month incidence of biopsy-proven acute rejection was similar in both arms (21.6% control, 16.7% MMF stop). Graft loss occurred in 5.4% (control) and 3.8% (MMF stop) of the patients. MMF could be safely discontinued from a tacrolimus-based triple therapy early after transplantation without any rebound in efficacy during the 6-month follow-up period. (Name of registry: ClinicalStudyResults.org, number: FG-02-CEE-01, date: 9 June 2006).
authors.affiliation: Department of Nephrology, Collegium Medicum of Jagiellonian University, Kraków, Poland. wladsul@mp.pl
authors.forename: Władysław
authors.initials: W
authors.lastname: Sułowicz
authors.forename: Petr
authors.initials: P
authors.lastname: Bachleda
authors.forename: Andrzej
authors.initials: A
authors.lastname: Rydzewski
authors.forename: Bolesław
authors.initials: B
authors.lastname: Rutkowski
authors.forename: Péter
authors.initials: P
authors.lastname: Szakály
authors.forename: Lászlo
authors.initials: L
authors.lastname: Asztalos
authors.forename: Jiri
authors.initials: J
authors.lastname: Samlik
authors.forename: Eva
authors.initials: E
authors.lastname: Lacková
authors.forename: Andrzej
authors.initials: A
authors.lastname: Ksiazek
authors.forename: Pavel
authors.initials: P
authors.lastname: Studenik
authors.forename: Michał
authors.initials: M
authors.lastname: Myśliwiec
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Hruby
authors.forename: Pavel
authors.initials: P
authors.lastname: Navrátil
authors.forename: Janusz
authors.initials: J
authors.lastname: Gumprecht
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus