235 A four-year analysis of immunosuppressive regimens and outcomes in Expanded Criteria Donor kidney transplant recipients from the Mycophenolic Acid Observational Renal Transplant Registry

Wednesday, October 24, 2012
Westin Diplomat Resort
Ali Olyaei, Pharm.D1, V. Ram Peddi, MD2, Anne Wiland, PharmD, BCPS3 and Kimi Ueda, Pharm.D2
1Oregon State University and Oregon Health and Science University, Portland, OR
2California Pacific Medical Center, San Francisco, CA
3Novartis Pharmaceuticals Corporation, East Hanover, NJ

Purpose: To compare long-term immunosuppressive practices and outcomes in expanded criteria donor (ECD) or standard criteria donor (SCD) graft recipients.

Methods: Mycophenolic Acid Observational Renal Transplant (MORE) is a prospective, observational registry of de novo kidney transplant recipients receiving mycophenolic acid (MPA) managed according to local practice. ECD was defined as donor ≥60 years, or 50-59 years with two of: hypertension, serum creatinine >1.5mg/dL, or cerebrovascular accident death.

Results: 103 ECD (29 mycophenolate mofetil [MMF], 74 enteric-coated mycophenolate sodium [EC-MPS]) and 838 SCD (277 MMF, 561 EC-MPS) patients were analyzed. Mean donor age in the ECD and SCD groups was 61 versus 39 years, respectively (p<0.01); mean recipient age was 62 versus 50 years (p=0.02). Use of induction (100% versus 99%), tacrolimus (97% versus 95%) and corticosteroids (74% versus 74%) was similar. Full MPA dose (2.0g MMF, 1.44g EC-MPS) was less frequent in ECD versus SCD patients at months 3, 24 and 36 (all p<0.03). Four-year biopsy-proven acute rejection (BPAR) rates were similar for ECD versus SCD patients (11% versus 13%, p=0.66), as was graft survival (91% versus 94%, p=0.12), but patient survival was lower for ECD patients (85% versus 96%, p<0.01). BPAR and graft survival were similar in the ECD and SCD groups for MMF versus EC-MPS. Patient survival in the SCD group was lower with MMF (93% versus EC-MPS 97%, p=0.01). Mean (SD) serum creatinine was 1.9 (1.0)mg/dL versus 1.5 (1.3)mg/dL in ECD versus SCD patients (p=0.05). Cardiovascular events occurred in 15% ECD and 7% SCD patients (p=0.01). Infections in the ECD group were more frequent with MMF versus EC-MPS (45% versus 22%, p=0.03).

Conclusion: BPAR and graft survival were similar in recipients of ECD or SCD grafts at four years after kidney transplantation despite higher donor and recipient ages and less frequent maintenance of full MPA dose.