Tests hydrochlorothiazide in adults with polycystic kidney disease
Compares hydrochlorothiazide with placebo in adults with polycystic kidney disease.
Plain-language title generated from the registry record
Registry title: HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
Key facts
- Where
- Berlin, Cologne, Dresden, and Leipzig, GermanySee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05373264, who can take part
Where in Germany
- Charite Universitatsmedizin Berlin KöRBerlin, GermanyTaking people
- Childrens Hospital University Of CologneCologne, GermanyTaking people
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT05373264EU 2022-500210-26-00
- Record updated
- 25 August 2026
- Original description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.Read full original descriptionShow less
HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
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 whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.
Inclusion: 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: Uncontrolled hypertension (blood pressure >160/100mmHg); History of active gout on maintenance preventive treatment for gout (allopurinol, desuric and/or colchicine), defined as ≥2 episodes during the last year; History of skin cancer (basal cell, squamous cell and melanoma); Hypokalemia (<3.5 mmol/L); Known intolerance to hydrochlorothiazide; Use of any diuretic; Orthostatic hypotension complaints or blood pressure <105/65mmHg during screening visit.