Steroid Avoidance with Early Intensified Dosing of Enteric-coated Mycophenolate Sodium: A Randomized Multicentre Trial in Kidney Transplant Recipients.
Thierry A, Mourad G, et al.Nephrology Dialysis Transplantation, 27(9):3651-3659, 2012.
Aims
To compare the efficacy and tolerability of a steroid avoidance regimen versus steroid maintenance therapy in de novo kidney transplant patients receiving cyclosporine (CsA) and early intensified dosing of enteric-coated mycophenolate sodium (EC-MPS).
Interventions
All patients received methylprednisolone on the day of transplantation and 1 day post-transplantation. Patients were randomized to withdraw steroids or remain on steroids. All patients received interleukin-2 receptor antibody (IL-2RA) induction, EC-MPS and cyclosporine. All patients were given pneumocystis jiroveci prophylaxis.
Participants
222 de novo kidney transplant recipients at low-immunological risk.
Outcomes
The primary endpoint was the incidence of treatment failure at Month 6, defined as clinical biopsy proved acute rejection (BPAR), graft loss, death or loss to follow-up. Secondary efficacy endpoints were the incidence and severity of clinical BPAR at Month 3 and 6, graft and patient survival rate, renal function measured as estimated glomerular filtration rate, serum creatinine and calculated creatinine clearance at Month 3 and 6, graft histology and treatment failure at Month 3. Safety endpoints were all adverse events related to EC-MPS or steroid therapy.
Follow-up
6 months
CET Conclusions
In renal transplant recipients at low immunological risk, more intense early treatment with enteric coated MPS did allow steroids to be avoided without any untoward effects. The patients were all induced with an IL-2 receptor antibody and cyclosporine was used with MPS for maintenance. There were less adverse events in the steroids avoidance group.
Data analysis
Available case analysis
Trial registration
NCT 980654 (ClinicalTrials.gov)