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| |  A Loading Dose of Mycophenolate Mofetil Increases Early Mean MPA Exposure and Decreases Rate of Acute Rejection: Presented at ATC By Cheryl Lathrop BOSTON -- June 3, 2009 -- A 3-gram loading dose of mycophenolate mofetil (MMF) decreases the rate of acute rejection within the first 6 months after kidney transplant by increasing early mean mycophenolic acid (MPA) exposure, researchers stated here at the 2009 American Transplant Congress (ATC). Sita Gourishankar, MD, MSc, University of Alberta Hospital, Edmonton, Alberta, and colleagues performed a prospective, randomised, open-label study comparing the efficacy and safety of a 3-g/day, 5-day MMF loading dose versus a standard 2-g MMF daily dose in renal allograft transplant recipients. This study investigated whether a loading dose increases the proportion of kidney transplant patients reaching MPA therapeutic levels by day 5 versus standard dosing. Findings were presented in a concurrent session here on May 31. The trial is dubbed the CLEAR Study -- A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants. The study population included adult de novo renal transplant patients approximately 45 years of age; half were Caucasian, half were male. The primary endpoint was the proportion of patients achieving the therapeutic window by day 5 (30 to 60 mg.h/L); the secondary endpoint was the proportion of patients achieving the therapeutic window by day 3, and by months 1, 3, and 6. The loading-dose arm (n = 68) received MMF 1.5 g twice daily (3 g/day) between days 1 and 5, then 1.0 g twice daily. The standard-dose arm (n = 67) received MMF 1.0 g twice daily (2 g/day). Tacrolimus was adjusted to trough levels of 8 to 12 ng/mL. All patients received steroids, and 85% received an interleukin-2 receptor blocker. MPA area-under-the-curve measurements were taken at days 3 and 5 and months 1 and 3. Acute rejection was defined as biopsy-proven, suspected, or treated. Of 65 evaluable patients in the MMF 3-g loading-dose arm, 47.5% achieved the MPA therapeutic window at day 5 compared with 54.4% of the 61 evaluable patients in the MMF 2-g standard-dose arm (P = nonsignificant). At day 3, MPA exposure was <30 mg.h/L in 14.1% of the 3-g arm versus 33.3% of the 2-g arm and >60 mg.h/L in 45.3% of the 3-g arm versus 16.7% of the 2-g arm (P = .0011). The incidence of acute rejection was 13.5% in the 3-g arm versus 30.6% in the 2-g arm (P = .0369). No significant differences were seen in common adverse events or MMF discontinuations between groups. [Presentation title: The CLEAR Study: A Prospective, Randomized, Controlled, Open-Label, Multicentre 6-Month Study Comparing the Efficacy and Safety of a 5-Day 3-g Daily Mycophenolate Mofetil (MMF) Loading Dose Versus Standard 2-g MMF Daily Dosing in Renal Allograft Transplant Recipients. Abstract 98]
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