Solid Organ Transplantation: The KidneyFK 506 and Mycophenolate Mofetil in Renal Transplant Recipients: Six-Month Results of a Multicenter, Randomized Dose Ranging Trial 1
Section snippets
Methods
This was an open-label, randomized, prospective study conducted at 13 centers in the United States. Recipients of a cadaveric kidney, 12 years of age or older, who met the inclusion/exclusion criteria were randomized within 24 hours of the transplant to AZA (1.5 mg/kg/d), MMF (1 g/d), or MMF (2 g/d) in combination with FK 506 and corticosteroids. The initial oral FK 506 dose of 0.10 mg/kg was given twice a day, starting between days 2 and 15 after transplant. Target whole blood trough FK 506
Patient Population
A total of 187 patients were enrolled in the study; 176 patients received at least one dose of FK 506 and are included in the analysis. The treatment groups were comparable with respect to patient and donor age, race, and gender and the etiology of the end-stage renal failure (Table 1). The mean number of total HLA mismatches was similar among the three randomized groups (3.3, 3.4, and 3.4 in the AZA, MMF 1g, and MMF 2g, respectively.)
A total of 31 (17.6%) patients discontinued the study due
Summary
The effective dose of MMF with FK 506 has not been previously studied in a prospective, randomized, controlled setting. In the present study, we evaluated two different daily doses of MMF (1 and 2 g) and compared it to the historically conventional therapy of AZA. At 6 months post-transplant, we found no significant difference in the incidence of acute rejection between the AZA group and the MMF 1 g group. However, patients who started on MMF 2 g/d had significantly delayed and lower incidence
Acknowledgements
The FK506 MMF Dose-Ranging Kidney Transplant Study Group: Mark B. Deierhoi, MD, University of Alabama at Birmingham; Ronald S. Filo, MD, Indiana University Medical Center, Indianapolis; Stephen C. Jensik, MD, Rush-Presbyterian-St. Luke’s Medical Center, Chicago; David Klassen, MD, University of Maryland, Baltimore; David Laskow, MD, Allegheny University Hospital, Philadelphia; Christopher Marsh, MD, University of Washington Medical Center, Seattle; Joshua Miller, MD, University of Miami;
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This research was funded by Fujisawa USA, Inc, Deerfield, Ill.