Autosomal dominant polycystic kidney disease (ADPKD)
Conditions
Brief summary
Annual slope of eGFR decline (in mL/min/1,73m2 per year, chronic slope), as calculated with linear mixed models, using all available creatinine values from week 6 until end of treatment (week 156)
Detailed description
Off-treatment values: eGFR change from before to after treatment (using the mean of two creatine measurements for each timepoint; week -4 and 0 for before treatment; week 162 and 168 for follow-up), Composite outcome: Sustained 40 % decrease in eGFR from randomization (confirmed by second measurement in next scheduled visit or measured at the last study follow-up visit / the last scheduled visit before death) • OR ESKD: start of dialysis or kidney transplantation or sustained eGFR <15 mL/min/1.73m2 • OR Renal death, Collection of SAEs and AEs of special interest, Change in total kidney volume after 1 year (first 150 patients; baseline – 48 weeks)
Interventions
DRUGMatching Placebo for "Dapagliflozin Ascend 10 mg Filmtabletten"
Sponsors
University Of Cologne
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual slope of eGFR decline (in mL/min/1,73m2 per year, chronic slope), as calculated with linear mixed models, using all available creatinine values from week 6 until end of treatment (week 156) | — |
Secondary
| Measure | Time frame |
|---|---|
| Off-treatment values: eGFR change from before to after treatment (using the mean of two creatine measurements for each timepoint; week -4 and 0 for before treatment; week 162 and 168 for follow-up), Composite outcome: Sustained 40 % decrease in eGFR from randomization (confirmed by second measurement in next scheduled visit or measured at the last study follow-up visit / the last scheduled visit before death) • OR ESKD: start of dialysis or kidney transplantation or sustained eGFR <15 mL/min/1.73m2 • OR Renal death, Collection of SAEs and AEs of special interest, Change in total kidney volume after 1 year (first 150 patients; baseline – 48 weeks) | — |
Countries
Austria, Germany, Netherlands, Spain
Outcome results
None listed