- In patients on low-dose cyclosporine (CsA), azathioprine (AZA) and mycophenolate mofetil (MMF) resulted in the same rate of chronic allograft nephropathy (CAN), clinical or subclinical acute cellular rejection (ACR), and graft survival and function.
- AZA is a less expensive alternative to MMF in low-dose maintenance immunosuppression.
Why this matters
- Previous studies suggested that MMF prevents ACR more effectively than AZA, but this effect has not been confirmed.
- Safety and efficacy of MMF and AZA in kidney transplant recipients on low-dose, steroid-free CsA is unknown.
- Randomized, placebo-controlled, prospective, multicenter trial comparing effects on CAN prevention of MMF vs AZA as the only immunosuppressant therapy for kidney transplant recipients.
- Patients (n=233) received low-dose thymoglobulin and basiliximab for induction; the CsA initial dose was tapered by 50% in patients with stable graft function, no previous acute kidney rejection, and no infiltrates at 1-year surveillance biopsy.
- Primary endpoint was the cumulative incidence of CAN at 3 years.
- At 3 years, CAN occurred in 38 patients (31.9%) on MMF vs 37 (32.4%) on AZA, and 22 (18.5%) patients on MMF vs 24 (21.1%) on AZA had biopsy-proven ACR (P=.72).
- A total of 11 (9.2%) patients on MMF vs 8 (7.0%) on AZA developed subclinical ACR (sCr increase
- Estimated glomerular filtration rate was similar between groups (P=.50); the CsA dose was tapered in 19 (16.0%) patients on MMF and in 21 (18.4%) on AZA.