Table 3:
Primary, secondary and exploratory efficacy endpoints and definition of ESKD.
| Efficacy endpoints |
|---|
| Primary composite endpoint |
| Time to onset of a ≥30% decrease in eGFR from baseline |
| Time to ESKD |
| Secondary endpoints |
| Important secondary composite endpoint |
| Time to onset of a ≥40% decrease in eGFR from baseline |
| Time to ESKD |
| Other secondary endpoints |
| Time to onset of a ≥53% decrease in eGFR from baselinea or ESKD |
| Time to onset of ESKD |
| Change in eGFR from baseline at each evaluation time point |
| Exploratory endpoints |
| Quality of life (Health Survey Short Form-36 and European Quality of Life 5-Dimension Questionnaire) |
| Definition of ESKD |
| Initiation of maintenance dialysis |
| Renal transplantation |
| Sustained eGFR ≤6 ml/min/1.73 m2 for ≥4 weeks |
| Other ESKD cases as determined by the Kidney Event Assessment Committee |
a
Equivalent to doubling of the serum creatinine level used as the conventional ESKD surrogate endpoint when converted to the percentage change in the eGFR based on the eGFR estimation equation of the Japanese Society of Nephrology.