title: Lack of benefit of early protocol biopsies in renal transplant patients receiving TAC and MMF: a randomized study.
abstract: We conducted a randomized, multicenter study to determine whether treatment of subclinical rejection with increased corticosteroids resulted in beneficial outcomes in renal transplant patients receiving tacrolimus (TAC), mycophenolate mofetil (MMF) and prednisone. One hundred and twenty-one patients were randomized to biopsies at 0,1,2,3 and 6 months (Biopsy arm), and 119 to biopsies at 0 and 6 months only (Control arm). The primary endpoint of the study was the prevalence of the sum of the interstitial and tubular scores (ci + ct)> 2 (Banff) at 6 months. Secondary endpoints included clinical and subclinical rejection and renal function. At 6 months, 34.8% of the Biopsy and 20.5% of the Control arm patients had a ci + ct score >or= 2 (p = 0.07). Between months 0 and 6, clinical rejection episodes were 12 in 10 Biopsy arm patients and 8 in 8 Control arm patients (p = 0.44). Overall prevalence of subclinical rejection in the Biopsy arm was 4.6%. Creatinine clearance at 6 months was 72.9 +/- 21.7 in the Biopsy and 68.90 mL/min +/- 18.35 mL/min in the Control arm patients (p = 0.18). In conclusion, we found no benefit to the procurement of early protocol biopsies in renal transplant patients receiving TAC, MMF and prednisone, at least in the short term. This is likely due to their low prevalence of subclinical rejection.
authors.affiliation: Health Sciences Centre, Winnipeg, Manitoba, Canada. drush@exchange.hsc.mb.ca
authors.forename: D
authors.initials: D
authors.lastname: Rush
authors.forename: D
authors.initials: D
authors.lastname: Arlen
authors.forename: A
authors.initials: A
authors.lastname: Boucher
authors.forename: S
authors.initials: S
authors.lastname: Busque
authors.forename: S M
authors.initials: SM
authors.lastname: Cockfield
authors.forename: C
authors.initials: C
authors.lastname: Girardin
authors.forename: G
authors.initials: G
authors.lastname: Knoll
authors.forename: J-G
authors.initials: JG
authors.lastname: Lachance
authors.forename: D
authors.initials: D
authors.lastname: Landsberg
authors.forename: J
authors.initials: J
authors.lastname: Shapiro
authors.forename: A
authors.initials: A
authors.lastname: Shoker
authors.forename: S
authors.initials: S
authors.lastname: Yilmaz
mesh_terms: D000328:Adult; D001706:Biopsy; D002170:Canada; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000276:immunology; D018579:Patient Selection; D011184:Postoperative Period; D011241:Prednisone / Q000627:therapeutic use; D015995:Prevalence; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D011241:Prednisone; D016559:Tacrolimus