Table 3 Primary and Secondary Endpoints
Endpoints | Period | |
|---|---|---|
Primary | Short-term | 1) The development of significant renal dysfunction 1. serum Cre level ≥ 1.5 times higher than that at 0 week 2. eGFR decrease ≥20 ml/min/1.73m2 from that at 0 week 3. proteinuria ≥3.5 g/gCr 4. new development of urinary stones 2) The occurrence of any kind of CVD and the death |
Secondary | Lon-term | 1) The development of significant renal dysfunction 2) The occurrence of any kind of CVD and the death |
Short-term & Lon-term | Reno-protective marker associated with alkalinizing agents in both periods of study, for example, category II (blood tests), categoryII (urine test), urine pH and unknown surrogate biomarkers of early renal damage, including uremic toxins and known metabolites measured by metabolomics. |