Treatment of subclinical injuries detected by protocol biopsy improves the long-term kidney allograft function: a single center prospective randomized clinical trial

Transplant Proc. 2011 May;43(4):1239-43. doi: 10.1016/j.transproceed.2011.03.078.


Background: The long-term benefit of early treatment of subclinical disorders detected in kidney allografts by protocol biopsy is controversial. We collected 145 protocol biopsies from 113 recipients for comparison with 51 control patients in a single-center, prospective, randomized trial.

Methods: Ultrasound-guided biopsies were performed in recipients with stable renal function. Samples were taken at 3 (n=66) and/or 12 months (n=79) after transplantation. The biopsies were evaluated according to the Banff scheme, and patients were treated based on the diagnosis. Changes in glomerular filtration rate (GFR) were compared with 51 patients who were randomized as a control group.

Results: The findings on 38 samples (29%) were considered to be normal. Based on the pathology findings, such as subclinical acute rejection (n=23), calcineurin inhibitor toxicity (n=28), chronic rejection (n=6), and other specific pathologies (n=23), including polyoma virus nephropathy (n=2), induced treatment among 82 recipients (57%). Significantly better graft function was observed at 3-year follow-up among the biopsy group, compared with controls: GFR = 46.0 ± 13.8 vs 35 ± 15 mL/min (P=.002). The 5-year graft survival was significantly higher in the biopsy (81%) than in the control (55.6%) group (P=.0012).

Conclusion: Early detection and treatment of subclinical pathologies improved graft function and long-term survival. Protocol biopsies were a valuable tool for posttransplantation management.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Asymptomatic Diseases
  • Biopsy
  • Chi-Square Distribution
  • Early Diagnosis
  • Female
  • Glomerular Filtration Rate
  • Graft Rejection / diagnosis
  • Graft Rejection / etiology
  • Graft Rejection / physiopathology
  • Graft Rejection / therapy*
  • Graft Survival*
  • Humans
  • Hungary
  • Immunosuppressive Agents / adverse effects*
  • Kidney Diseases / diagnosis
  • Kidney Diseases / etiology
  • Kidney Diseases / physiopathology
  • Kidney Diseases / therapy*
  • Kidney Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • Time Factors
  • Treatment Outcome


  • Immunosuppressive Agents