title: Early corticosteroid avoidance in kidney transplant recipients receiving ATG-F induction: 5-year actual results of a prospective and randomized study.
abstract: One hundred ninety-seven patients received anti-T-lymphocyte globulins Fresenius, mycophenolate mofetil and delayed cyclosporine, and were randomized to ≥6-month corticosteroids (+CS; n=99) or no CS (-CS; n=98). One- and five-year actual graft survival (censored for death) was 93.2% and 86.4% in the +CS group versus 94.9% and 89.8% in the -CS group (5-year follow-up, p=0.487). Freedom from clinical rejection was 86.9% and 81.8% versus 74.5% and 74.5% (p=0.144), respectively, at 1 and 5 years; 5-year freedom from biopsy-proven rejection was 88.9% versus 83.7% (p=0.227). More late first rejections occurred in the +CS group. Significantly lower 5-year graft survival in patients experiencing rejection was observed for +CS (55.6% vs. 92.0%; p=0.005) with 8/18 versus 2/25 graft losses. Renal function at 5 years was stable and comparable (median serum creatinine, 159 vs. 145 µmol/L; creatinine clearance, 53.5 vs. 56.6 mL/min). More +CS patients developed diabetes, dyslipidemia and malignancies. Rejections in -CS patients occurred early after transplantation and did not impair long-term renal function. In patients receiving CS, rejections occurred later and with a higher risk for subsequent graft failure. A similar and not inferior 5-year efficacy profile and a reduced morbidity were observed in CS-free patients compared to patients who received CS for at least 6 months.
authors.affiliation: Institut de Transplantation-Urologie-Néphrologie (ITUN), Centre Hospitalier et Universitaire de Nantes, Nantes, France.
authors.forename: D
authors.initials: D
authors.lastname: Cantarovich
authors.forename: L
authors.initials: L
authors.lastname: Rostaing
authors.forename: N
authors.initials: N
authors.lastname: Kamar
authors.forename: D
authors.initials: D
authors.lastname: Ducloux
authors.forename: Y
authors.initials: Y
authors.lastname: Saint-Hillier
authors.forename: G
authors.initials: G
authors.lastname: Mourad
authors.forename: V
authors.initials: V
authors.lastname: Garrigue
authors.forename: P
authors.initials: P
authors.lastname: Wolf
authors.forename: B
authors.initials: B
authors.lastname: Ellero
authors.forename: E
authors.initials: E
authors.lastname: Cassuto
authors.forename: L
authors.initials: L
authors.lastname: Albano
authors.forename: A
authors.initials: A
authors.lastname: Völp
authors.forename: J-P
authors.initials: JP
authors.lastname: Soulillou
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006085:Graft Survival; D006801:Humans; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate; D019172:Transplantation Conditioning; D016896:Treatment Outcome; D055815:Young Adult