Study Endpoints

Primary Endpoint

• Transition to overt nephropathy
  • first-morning voided urine albumin:creatinine ratio (UACR) >300 mg/g at two consecutive 4-week visits
  • UCAR increase ≥ 30% from baseline at two consecutive 4-week visits

Secondary Endpoint

• Changes in the urinary albumin: creatinine ratio
• Transition rate to overt nephropathy
• Normalization rate of UACR (<30 mg/g creatinine)
• Changes in serum creatinine
• Changes in serum creatinine clearance
• Changes in urinary collagen Type IV
• Composite of a doubling of serum creatinine concentration, ESRD, or death
• Composite of mortality and morbidity from cardiovascular disorders

References