Early Steroid Withdrawal and Optimization of Mycophenolic Acid Exposure in Kidney Transplant Recipients Receiving Mycophenolate Mofetil.
Le Meur Y, Thierry A, et al.Transplantation 92(11):1244-51, 2011
Aims
To evaluate the feasibility and safety of early steroid withdrawal in low-risk patients receiving cyclosporine A (CsA) and the impact of optimization of mycophenolic acid exposure on steroid withdrawal.
Interventions
Adjusted dose of mycophenolate mofetil (MMF) using therapeutic drug monitoring versus a fixed-dose regimen.
Participants
258 de novo low-immunological risk kidney recipients.
Outcomes
The primary efficacy endpoint was the proportion of patients experiencing biopsy-proven acute rejection (BPAR) on indicated biopsies and those with subclinical acute rejection (SCAR) identified on the 3-month protocol biopsy. The secondary efficacy endpoints were the proportion of patients with a BPAR or a SCAR episode at 1 year, renal function measured as creatinine clearance and graft and patient survival. Other outcomes included anemia, leucopenia total gastrointestinal adverse events (diarrhea, constipation, anorexia, abdominal pain, nausea, or vomiting), infections and new onset diabetes
Follow-up
1 year
CET Conclusions
In kidney recipients considered to be of low immunological risk, MMF combined with CsA allows early steroid withdrawal with no increase in rejection and the therapeutic monitoring of MMF did not improve clinical outcome.
Data analysis
Modified intention-to-treat analysis
Quality notes
This is a follow-up study of a previous publication: Vincenti F, Charpentier B, Vanrenterghem Y, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant 2010; 10: 535–546. The methodological quality assessment was based on the previous paper.
Trial registration
2006-000352-41(EUDRACT)