BioCentury
ARTICLE | Clinical News

Astragraf XL tacrolimus: Phase IIIb data

March 2, 2015 8:00 AM UTC

The open-label, international Phase IIIb DIAMOND trial in 893 patients showed that once-daily low-dose (0.15-0.175 mg/kg) Advagraf in combination with Simulect basiliximab and mycophenolate mofetil (MMF) met the primary endpoint of increasing GFR as measured by the MDRD4 formula vs. once-daily 0.2 mg/kg Advagraf plus MMF (76.4 vs. 67.4 mL/min/1.73m2, 95% CI: 3.3, 14.8, p=0.001). The normal dose of Advagraf is 0.2 mg/kg. Low-dose Advagraf plus MMF and Simulect met the secondary endpoints of lowering the incidence of BCAR, increasing the creatinine clearance as measured by Cockcroft-Gault and increasing the eGFR as measured by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) vs. normal-dose Advagraf plus MMF. Low-dose Advagraf plus MMF and Simulect missed the secondary endpoints of increasing eGFR as measured by cystatin C and as measured by iohexol clearance vs. normal-dose Advagraf plus MMF. ...