Chronic Kidney Disease and High Proteinuria
Conditions
Brief summary
Change in eGFR from baseline to Month 24
Detailed description
1.Change in UPCR from baseline to each participant’s mean level across the visits from Day 15 up to Month 24., 2.Change in UACR from baseline to each participant’s mean level across the visits from Day 15 up to Month 24., 3. Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death, 4. Change from baseline in systolic blood pressure from baseline to each participant’s mean level across the visits from Day 15 up to Month 24., 5. Proportion of participants achieving UPCR < 1000 mg and > 30% reduction from baseline for each participant’s mean level across the visits from Day 15 up to Month 24.
Interventions
DRUGDAPAGLIFLOZIN
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in eGFR from baseline to Month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in UPCR from baseline to each participant’s mean level across the visits from Day 15 up to Month 24., 2.Change in UACR from baseline to each participant’s mean level across the visits from Day 15 up to Month 24., 3. Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death, 4. Change from baseline in systolic blood pressure from baseline to each participant’s mean level across the visits from Day 15 up to Month 24., 5. Proportion of participants achieving UPCR < 1000 mg and > 30% reduction from baseline for each participant’s mean level across the visits from Day 15 up to Month 24. | — |
Countries
Austria, Bulgaria, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden
Outcome results
None listed