Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
Brief summary
The rate of kidney function decline (expressed as eGFR slope, in mL/min/1.73m2 per year), as calculated by linear mixed model analysis, using all available creatinine values from week 12 until week 156 (EoT) for HCT- versus placebo-treated patients.
Detailed description
1) changes in eGFR between baseline and EoS (off treatment) 2) incidence of a 30% decrease in eGFR, end stage kidney disease or death from renal causes 3) changes in quality of life related questionnaire scores (TIPS, ADPKD-UIS, EQ-5D-5L and SF-12) 4) changes in 24-hour urine volume 5) tolvaptan dose and discontinuation rate 6) changes in serum electrolytes (potassium, sodium, calcium and phosphate) 7) changes in blood pressure
Interventions
DRUGPlacebo Role : Placebo Name : Placebo of HYDROCHLOROTHIAZIDE
DRUGHYDROCHLOROTHIAZIDE
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of kidney function decline (expressed as eGFR slope, in mL/min/1.73m2 per year), as calculated by linear mixed model analysis, using all available creatinine values from week 12 until week 156 (EoT) for HCT- versus placebo-treated patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) changes in eGFR between baseline and EoS (off treatment) 2) incidence of a 30% decrease in eGFR, end stage kidney disease or death from renal causes 3) changes in quality of life related questionnaire scores (TIPS, ADPKD-UIS, EQ-5D-5L and SF-12) 4) changes in 24-hour urine volume 5) tolvaptan dose and discontinuation rate 6) changes in serum electrolytes (potassium, sodium, calcium and phosphate) 7) changes in blood pressure | — |
Countries
Belgium, France, Germany, Netherlands, Spain
Outcome results
None listed