Trial · NCT05373264
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in kidney function decline | 156 weeks | The primary outcome is the change in kidney function decline (assessed as eGFR slope, in ml/min/1.73 m2 per year), calculated with linear mixed models, using all available creatinine values from week 12 until end of treatment between the tolvaptan/placebo and tolvaptan/HCT group. |
| Secondary | Changes in eGFR from baseline compared to end of study (12 weeks after End of Treatment) | 168 weeks | A secondary outcome is the change in eGFR from baseline compared to end of study (12 weeks after end of treatment) |
| Secondary | Incidence of 30% decrease in eGFR, end stage kidney disease (EKSD) or renal death | 168 weeks | A secondary outcome is the incidence of a 30% decrease in eGFR, occurrence of end stage kidney disease (EKSD) or renal death during the entire study period (until the end of study (12 weeks after end of treatment) |
| Secondary | Changes in 24-hour urine volume | 156 weeks | A secondary outcome is the change in 24-hour urine volume, measured at baseline, week 12, week 48, week 96 and week 156 (end of treatment) |
| Secondary | Quality of life, assessed by the TIPS questionnaire | 156 weeks | Changes in Quality of Life measured by the Tolvaptan Impact of Polyuria Scale questionnaire (TIPS) at baseline, week 12, week 48, week 96 and week 156 (end of treatment) |
| Secondary | Quality of life, assessed by the ADPKD-UIS questionnaire | 156 weeks | Changes in Quality of Life measured by the ADPKD-Urinary Impact Scale questionnaire (ADPKD-UIS) at baseline, week 12, week 48, week 96 and week 156 (end of treatment) |
| Secondary | Quality of life, assessed by the SF-12 questionnaire | 156 weeks | Changes in Quality of Life measured by the Short Form 12 questionnaire (SF-12) at baseline, week 12, week 48, week 96 and week 156 (end of treatment) |
| Secondary | Quality of life, assessed by the EQ-5D questionnaire | 156 weeks | Changes in Quality of Life measured by the EuroQol-5 Dimension questionnaire (EQ-5D) at baseline, week 12, week 48, week 96 and week 156 (end of treatment) |
| Secondary | Change in V2RA dose | 168 weeks | V2RA dose during each study visit and compared at the end of study visit (12 weeks after end of treatment) between tolvaptan/placebo and tolvaptan/hydrochlorothiazide group |
| Secondary | Change in V2RA discontinuation rate | 168 weeks | The V2RA discontinuation rate will be compared at the end of study visit (12 weeks after end of treatment) between tolvaptan/placebo and tolvaptan/hydrochlorothiazide group |
| Secondary | Changes in serum sodium concentration | 168 weeks | Changes in serum sodium concentration between tolvaptan/placebo and tolvaptan/hydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment) |
| Secondary | Changes in serum potassium concentration | 168 weeks | Changes in serum potassium concentration between tolvaptan/placebo and tolvaptan/hydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment) |
| Secondary | Changes in plasma serum calcium concentration | 168 weeks | Changes in plasma serum calcium concentration between tolvaptan/placebo and tolvaptan/hydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment) |
| Secondary | Changes in serum phosphate concentration | 168 weeks | Changes in serum phosphate concentration between tolvaptan/placebo and tolvaptan/hydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment) |
| Secondary | Incidence of (serious) adverse events | 168 weeks | Incidence of (serious) adverse events from baseline until the end of study (12 weeks after end of treatment) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05373264/registered