NCT05373264RecruitingPhase 3
HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 28 Apr 2022
- Start date
- 31 Jul 2024
- Primary completion date
- Jul 2030
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Polycystic kidney disease
- NCT number
- NCT05373264
- EU CT number
- 2022-500210-26-00
- EudraCT number
- 2021-005612-61
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 31 Jul 2024 to the primary completion date, Jul 2030
- 25 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Hypokalemia (\<3.5 mmol/L)
Other
- Known intolerance to hydrochlorothiazide
- Use of any diuretic
- Orthostatic hypotension complaints or blood pressure \<105/65mmHg during screening visit
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Graz Coordinator of this site? Confirm its status | Graz | Austria | Not yet recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Not yet recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Universitätsspital Bern (Inselsspital) Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Hopital Fribourgeois HFR Coordinator of this site? Confirm its status | Fribourg | Switzerland | Recruiting |
| Hôpitaux Universitaires de Genève (HUG) Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| Universitätsspital Zürich USZ Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Charite Universitatsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Childrens Hospital University Of Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Hospital General La Mancha Centro Coordinator of this site? Confirm its status | Alcázar de San Juan | Spain | Recruiting |
| Fundació Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Pellegrin Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Hospital Edouard Herriot Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Recruiting |
| VU University Medical Centre Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.