title: Minimization of maintenance immunosuppressive therapy after renal transplantation comparing cyclosporine A/azathioprine or cyclosporine A/mycophenolate mofetil bitherapy to cyclosporine A monotherapy: a 10-year postrandomization follow-up study.
abstract: Long-term outcomes in renal transplant recipients withdrawn from steroid and submitted to further minimization of immunosuppressive regimen after 1 year are lacking. In this multicenter study, 204 low immunological risk kidney transplant recipients were randomized 14.2 ± 3.7 months post-transplantation to receive either cyclosporine A (CsA) + azathioprine (AZA; n = 53), CsA + mycophenolate mofetil (MMF; n = 53), or CsA monotherapy (n = 98). At 3 years postrandomization, the occurrence of biopsy for graft dysfunction was similar in bitherapy and monotherapy groups (21/106 vs. 26/98; P = 0.25). At 10 years postrandomization, patients' survival was 100%, 94.2%, and 95.8% (P = 0.25), and death-censored graft survival was 94.9%, 94.7%, and 95.2% (P = 0.34) in AZA, MMF, and CsA groups, respectively. Mean estimated glomerular filtration rate was 70.4 ± 31.1, 60.1 ± 22.2, and 60.1 ± 19.0 ml/min/1.73 m(2), respectively (P = 0.16). The incidence of biopsy-proven acute rejection was 1.4%/year in the whole cohort. None of the patients developed polyomavirus-associated nephropathy. The main cause of graft loss (n = 12) was chronic antibody-mediated rejection (n = 6). De novo donor-specific antibodies were detected in 13% of AZA-, 21% of MMF-, and 14% of CsA-treated patients (P = 0.29). CsA monotherapy after 1 year is safe and associated with prolonged graft survival in well-selected renal transplant recipient (ClinicalTrials.gov number: 980654).
authors.affiliation: Service de Néphrologie-Hémodialyse-Transplantation rénale, CHU de Poitiers, Poitiers, France.|Institut National de la Santé et de la Recherche Médicale U1082, Poitiers, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Thierry
authors.affiliation: Service de Néphrologie, CHRU, Brest, France.
authors.forename: Yannick
authors.initials: Y
authors.lastname: Le Meur
authors.affiliation: Service de Néphrologie-Hémodialyse-Transplantation rénale, CHU de Poitiers, Poitiers, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Ecotière
authors.affiliation: Service de Néphrologie-Hémodialyse-Transplantation rénale, CHU de Poitiers, Poitiers, France.
authors.forename: Ramzi
authors.initials: R
authors.lastname: Abou-Ayache
authors.affiliation: Service de Néphrologie, CHRU, Rouen, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Etienne
authors.affiliation: Service de Néphrologie, CHRU, Reims, France.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Laurent
authors.affiliation: Service de Néphrologie, CHRU, Reims, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Vuiblet
authors.affiliation: Service de Néphrologie, CHRU, Reims, France.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Colosio
authors.affiliation: Service de Néphrologie, CHRU, Caen, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Bouvier
authors.affiliation: Service de Néphrologie, CHRU, Limoges, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Aldigier
authors.affiliation: Service de Néphrologie, CHRU, Limoges, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Rerolle
authors.affiliation: Service de Néphrologie-Hémodialyse-Transplantation rénale, CHU de Poitiers, Poitiers, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Javaugue
authors.affiliation: Service de Néphrologie-Hémodialyse-Transplantation rénale, CHU de Poitiers, Poitiers, France.
authors.forename: Elise
authors.initials: E
authors.lastname: Gand
authors.affiliation: Service de Néphrologie-Hémodialyse-Transplantation rénale, CHU de Poitiers, Poitiers, France.
authors.forename: Frank
authors.initials: F
authors.lastname: Bridoux
authors.affiliation: Service de Néphrologie, CHRU, Limoges, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Essig
authors.affiliation: Service de Néphrologie, CHRU, Caen, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Hurault de Ligny
authors.affiliation: Service de Néphrologie-Hémodialyse-Transplantation rénale, CHU de Poitiers, Poitiers, France.|Institut National de la Santé et de la Recherche Médicale U1082, Poitiers, France.
authors.forename: Guy
authors.initials: G
authors.lastname: Touchard
mesh_terms: D000328:Adult; D001379:Azathioprine / Q000008:administration & dosage* / Q000009:adverse effects; D003524:Cyclosporins / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016030:Kidney Transplantation / Q000009:adverse effects / Q000379:methods / Q000401:mortality*; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011446:Prospective Studies; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003524:Cyclosporins; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D001379:Azathioprine
keywords: cyclosporine A; kidney transplantation; minimization; steroid-free maintenance immunosuppression