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Kidney Week

Abstract: FR-OR135

Mycophenolate Mofetil vs. Azathioprine in Kidney Transplant Recipients on Steroid-Free, Low-Dose Cyclosporine Immunosuppression: The ATHENA Trial

Session Information

  • High-Impact Clinical Trials
    November 08, 2019 | Location: Ballroom C, Walter E. Washington Convention Center
    Abstract Time: 03:00 PM - 03:15 PM

Category: Transplantation

Authors

  • Cravedi, Paolo, Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Ruggenenti, Piero Luigi, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy
  • Peraro, Francesco, Istituto Mario Negri, Albino, Italy
  • Perna, Annalisa, Mario Negri Institute, Milano, Italy
  • Remuzzi, Giuseppe, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Italy

Group or Team Name

  • For the ATHENA Study Group, Italy
Background

Registration trials with old sandimmune formulation of cyclosporine (CsA) suggested that Mycophenolate Mofetil (MMF) prevents acute cellular rejection (ACR) more effectively than Azathioprine (AZA), but multiple trials with standard-dose of more stable microemulsion formulation of CsA (Neoral) did not confirm this. The safety/efficacy of MMF and AZA in kidney transplant recipients on steroid-free, low-dose CsA Neoral is unknown.

Methods

The ATHENA trial (NCT00494741) was a randomized, prospective, multicenter trial comparing THe Effect on chronic allograft Nephropathy prevention of mycophenolate mofetil versus Azathioprine as the sole immunosuppressant for kidney transplant recipients. All patients were induced with low-dose Thymo + basiliximab. Those with stable graft function, no previous ACRs and no infiltrates at 1-yr surveillance biopsy underwent CsA tapering to half of the initial dose. Primary endpoint was cumulative incidence of chronic allograft nephropathy (CAN) at 3 yrs.

Results

We included 233 patients (119 on MMF; 114 on AZA). At 3 yrs, 38 patients on MMF (31.9%) vs 37 on AZA (32.4%) developed CAN (Figure); 22 on MMF (18.5%) vs 24 on AZA (21.1%) had biopsy-proven ACR (p=0.72); 11 on MMF (9.2%) and 8 on AZA (7.0%) had sub-clinical (sCreat increase <10% during previous 3 mo) ACR at 1-yr surveillance biopsy (p=0.47); 6 on MMF (5.0%) vs 7 on AZA (6.1%) had graft failure (p=0.54). 3-yr eGFR was similar between MMF and AZA groups (53.8±20.2 vs 51.4±18.8 ml/min/1.73m2, p=0.50). 19 patients on MMF (16.0%) vs 21 on AZA (18.4%) successfully tapered CsA doses, with only one ACR episode per arm. Post-tapering eGFR was stable.

Conclusion

In kidney transplant recipients on low-dose CsA and no steroids, AZA and MMF are associated with similar incidence of CAN, of clinical or subclinical ACR, and similar graft survival and function. AZA represents a valuable, less expansive, alternative to MMF also on low-dose maintenance immunosuppression.

Kaplan-Meier of CAN incidence in the two study arms.

Funding

  • Government Support - Non-U.S.