title: A randomized trial of intensified vs. standard dosing for enteric-coated mycophenolate sodium in de novo kidney transplant recipients: results at 1 year.
abstract: In a 6-month prospective, openlabel, multicenter study, 128 de novo kidney transplant patients receiving cyclosporine (CsA) and steroids were randomized to an intensified regimen of enteric-coated mycophenolate sodium (EC-MPS) or to a standard EC-MPS regimen to Week 6 posttransplant, after which the regimen was identical. In a follow-up study to Month 12 post-transplant (49 intensified regimen, 52 standard regimen), the reduced rate of BPAR observed at Month 6 (intensified regimen 3.2%, standard regimen 16.9%, p = 0.016) was maintained at Month 12 (4.8% vs. 18.5%, p = 0.026). Estimated GFR (Cockcroft-Gault) at Month 12 was comparable in the intensified group (mean (SD) 54.8 (22.9) ml/min) vs. the standard group (mean (SD) 57.5 (23.6) ml/min, p = 0.83). The incidence of adverse events and serious adverse events at Month 12 was similar in both treatment groups, although adverse events with a suspected relation to study drug were reported in 69.8% and 50.8% of patients in the intensified and standard regimen groups, respectively (p = 0.032). Infections and hematological parameters were similar between groups. In conclusion, an early regimen of intensified EC-MPS with CsA and steroids achieves a low rate of BPAR over the first year after kidney transplantation with similar renal function to a standard regimen, and without a clinically relevant impact on safety.
authors.affiliation: Department of Nephrology, Medical Clinic Köln-Merheim, Cologne, Germany. wolfgang.arns@uni-koeln.de
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Arns
authors.forename: Claudia
authors.initials: C
authors.lastname: Sommerer
authors.forename: Petra
authors.initials: P
authors.lastname: Glander
authors.forename: Toofan
authors.initials: T
authors.lastname: Ariatabar
authors.forename: Martina
authors.initials: M
authors.lastname: Porstner
authors.forename: Christoph
authors.initials: C
authors.lastname: May
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Paulus
authors.forename: Maria
authors.initials: M
authors.lastname: Shipkova
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Fischer
authors.forename: Lutz
authors.initials: L
authors.lastname: Liefeldt
authors.forename: Ruth
authors.initials: R
authors.lastname: Hackenberg
authors.forename: Peter
authors.initials: P
authors.lastname: Schemmer
authors.forename: Sophie
authors.initials: S
authors.lastname: Domhan
authors.forename: Martin
authors.initials: M
authors.lastname: Zeier
authors.forename: Klemens
authors.initials: K
authors.lastname: Budde
mesh_terms: D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D005919:Glomerular Filtration Rate; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016030:Kidney Transplantation / Q000379:methods; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011446:Prospective Studies; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D009173:Mycophenolic Acid