Randomized trial of conversion from mycophenolate mofetil to azathioprine 6 months after renal allograft transplantation

Nephrol Dial Transplant. 2000 Aug;15(8):1228-31. doi: 10.1093/ndt/15.8.1228.


Background: In the first year after renal allograft transplantation, triple therapy immunosuppression with cyclosporin (CsA), prednisone (P), and mycophenolate mofetil (MMF) is superior to a triple therapy treatment that includes azathioprine (AZA) instead of MMF. Whether long-term treatment with CsA-P-MMF is better than treatment with CsA-P-AZA is a matter of debate, as 3-year graft survival is similar in MMF- and AZA-treated patients. The purpose of the present study was to examine the short-term effect of changing MMF to AZA in low-risk renal allograft recipients 6 months after transplantation.

Method: This was a randomized, open-label single-centre study, recruiting 48 low risk renal allograft recipients on CsA-P-MMF therapy 6 months after transplantation, comparing the outcome with continued MMF treatment (2 g b.i.d.) (group A, n=22) or switching MMF to AZA (1 mg/kg) treatment (group B, n=26).

Results: The outcome after a 6-months follow-up of patients in group A and group B was similar. Treatment failure rates (defined as clinically diagnosed acute rejection episodes) were 4.5% in group A and 3.8% in group B. There were no patient deaths and no graft failures during the 6-months observation period. Graft function was excellent and similar in both groups.

Conclusion: Replacing MMF with AZA 6 months after transplantation in low-risk renal allograft recipients is safe and is not associated with altered graft function in the short term.

Publication types

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

MeSH terms

  • Acute Disease
  • Adult
  • Azathioprine / therapeutic use*
  • Female
  • Graft Rejection / epidemiology
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Incidence
  • Kidney / physiopathology
  • Kidney Transplantation*
  • Male
  • Middle Aged
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / therapeutic use*
  • Postoperative Period
  • Retreatment
  • Time Factors
  • Transplantation, Homologous
  • Treatment Outcome


  • Immunosuppressive Agents
  • Mycophenolic Acid
  • Azathioprine