title: Alemtuzumab induction and sirolimus plus mycophenolate mofetil maintenance for CNI and steroid-free kidney transplant immunosuppression.
abstract: We performed a pilot study in which 22 kidney recipients (14 LD: 8 DCD) were given alemtuzumab induction (30 mg day 0 and 1), steroids (500 mg mp day 0 and 1, none thereafter), mycophenolate mofetil (MMF) maintenance (500 mg b.i.d) and sirolimus (concentration controlled 8-12 ng/mL). With a mean follow-up of 15.9 months, patient survival is (21/22) 96% and graft survival (19/22) 87%. Acute rejections occurred in (8) 36.3% (two humoral). Of 19 surviving grafts, 18 (95%) remain steroid and 15 (79%) CNI-free. At 1 year, mean creatinine was 1.43 mg/dL. Overall infection rates were low, but 2 patients developed severe acute respiratory distress syndrome (ARDS) at month 3 and 7, respectively, resulting in mortality in one and a graft loss in the other. No cancer or PTLD was observed. Leukopenia was common and MMF dose was reduced or eliminated in 6/22 (27%) patients. The reported higher than expected rate of acute rejection, leukopenia and possible pulmonary toxicity suggests excessive morbidity. Modifications such as an initial period of CNI use should be considered.
authors.affiliation: Transplant Center, Cleveland Clinic Foundation, Cleveland, Ohio, USA. flechns@ccf.org
authors.forename: S M
authors.initials: SM
authors.lastname: Flechner
authors.forename: P J
authors.initials: PJ
authors.lastname: Friend
authors.forename: J
authors.initials: J
authors.lastname: Brockmann
authors.forename: H R
authors.initials: HR
authors.lastname: Ismail
authors.forename: M
authors.initials: M
authors.lastname: Zilvetti
authors.forename: D
authors.initials: D
authors.lastname: Goldfarb
authors.forename: C
authors.initials: C
authors.lastname: Modlin
authors.forename: B
authors.initials: B
authors.lastname: Mastroianni
authors.forename: K
authors.initials: K
authors.lastname: Savas
authors.forename: A
authors.initials: A
authors.lastname: Devaney
authors.forename: M
authors.initials: M
authors.lastname: Simmonds
authors.forename: D J
authors.initials: DJ
authors.lastname: Cook
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy*; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007239:Infections; D007668:Kidney / Q000473:pathology / Q000502:physiology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010865:Pilot Projects; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013256:Steroids
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D013256:Steroids; D000074323:Alemtuzumab; D009173:Mycophenolic Acid; D020123:Sirolimus