PMID: 8607174Mar 15, 1996Paper

Mycophenolate mofetil for the treatment of refractory, acute, cellular renal transplant rejection. The Mycophenolate Mofetil Renal Refractory Rejection Study Group

Transplantation

Abstract

In a 6-month open label, randomized, multicenter trial, we compared the efficacy and safety of mycophenolate mofetil (MMF) with high dose intravenous steroids (IVS) for the treatment of refractory, acute cellular rejection in recipients of first or second cadaveric or living-donor renal allografts. A total of 150 patients were enrolled and randomized in a 1-to-1 ratio to receive oral MMF 1.5 g twice daily (n=77) or i.v. methylprednisolone 5 mg/kg for 5 days (n= 73), tapered over the subsequent 5 days to 20 mg/day or the baseline dose of steroid given on the day before the diagnosis of rejection. Patients in both groups generally received cyclosporine and maintenance doses of corticosteroids throughout the study period. The IVS group (but not the MMF group) was generally maintained on azathioprine. The primary efficacy variable was graft and patient survival at 6 months. Graft loss and death were reduced by 45% in the MMF treatment group; 19 patients (26.0%) in the IVS group experienced graft loss or died, compared with 11 patients (14.3%) in the MMF group (P=0.081, sequential probability ratio test analysis). In the IVS group, 64.4% of patients experienced either subsequent biopsy proven rejection, presumptive rejection (presum...Continue Reading

Citations

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