Use of 12-month renal function and baseline clinical factors to predict long-term graft survival: application to BENEFIT and BENEFIT-EXT trials

Transplantation. 2012 Jan 27;93(2):172-81. doi: 10.1097/TP.0b013e31823ec02a.

Abstract

Background: Innovation in renal transplant management would benefit from identification of early markers that accurately predict long-term graft survival.

Methods: Data from the United States Renal Data System for kidney transplant recipients (1995-2004) were analyzed to develop prediction models for all-cause graft survival based on estimated glomerular filtration rate (eGFR), the presence or absence of acute rejection within 1 year, and recipient and donor demographic characteristics. The prediction models were applied to participants in the Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial and Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial--EXTended criteria donors trials comparing belatacept with cyclosporine in standard criteria donor (SCD) and expanded criteria donor (ECD) graft recipients, respectively, as an external validation of the model predictions in a diverse population.

Results: Compared with eGFR 60 mL/min/1.73 m(2), the relative hazard for all-cause graft loss increased in an accelerating pattern with lower GFR to approximately eight and seven times, respectively, among SCD and ECD recipients with eGFR less than 15 mL/min/1.73 m(2). When applied to the clinical trial samples, the predicted differences in all-cause graft survival of less intensive belatacept versus cyclosporine at the second transplant anniversary (SCD: 3.9%, 95% confidence interval [CI]: 3.6% to 4.2%; ECD: 4.1%, 95% CI: 3.5% to 4.7%) were similar to observed differences (SCD: 4.2%, 97.3% CI: -1.3% to 10.1%; ECD: 1.4%, 97.3% CI: -7.5% to 10.2%).

Conclusions: Accurate models of long-term graft survival can be developed using eGFR, donor, and recipient characteristics. Long-term survival prediction models may provide an efficient method for assessing the impact of novel pharmaceutical agents and clinical management protocols.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abatacept
  • Adolescent
  • Adult
  • Aged
  • Child
  • Cyclosporine / therapeutic use
  • Databases, Factual
  • Female
  • Glomerular Filtration Rate
  • Graft Survival / immunology
  • Graft Survival / physiology*
  • Humans
  • Immunoconjugates / therapeutic use*
  • Immunosuppressive Agents / therapeutic use*
  • Kidney Function Tests
  • Kidney Transplantation / immunology
  • Kidney Transplantation / physiology*
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Proportional Hazards Models
  • Time Factors
  • Tissue Donors
  • Tissue and Organ Procurement
  • United States
  • Young Adult

Substances

  • Immunoconjugates
  • Immunosuppressive Agents
  • Abatacept
  • Cyclosporine