HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
Recruiting
Phase 3
Interventional Study
ADPKD
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- University Medical Center Groningen · Other
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About This Trial
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.
Tolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test wheth…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* ADPKD diagnosis (modified Ravine criteria)
* ≥18 years old
* eGFR \> 25 mL/min/1.73m2
* On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months
Exclusion Criteria:
* Known intolerance to hydrochlorothiazide
* Use of any diuretic
* Orthostatic hy…
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