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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
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

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Hospital Graz
Coordinator of this site? Confirm its status
GrazAustriaNot yet recruiting
Medizinische Universitaet Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaNot yet recruiting
Universitair Ziekenhuis Antwerpen
Coordinator of this site? Confirm its status
EdegemBelgiumRecruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumRecruiting
Universitätsspital Bern (Inselsspital)
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting
Hopital Fribourgeois HFR
Coordinator of this site? Confirm its status
FribourgSwitzerlandRecruiting
Hôpitaux Universitaires de Genève (HUG)
Coordinator of this site? Confirm its status
GenevaSwitzerlandRecruiting
Universitätsspital Zürich USZ
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting
Charite Universitatsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Childrens Hospital University Of Cologne
Coordinator of this site? Confirm its status
CologneGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Coordinator of this site? Confirm its status
DresdenGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Hospital General La Mancha Centro
Coordinator of this site? Confirm its status
Alcázar de San JuanSpainRecruiting
Fundació Puigvert
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BarcelonaSpainRecruiting
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Pellegrin Hospital
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Hospitalier Régional et Universitaire de Brest
Coordinator of this site? Confirm its status
BrestFranceRecruiting
Hospital Edouard Herriot
Coordinator of this site? Confirm its status
Lyon Cedex 03FranceRecruiting
Hopital Necker Enfants Malades
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHRU De Nancy
Coordinator of this site? Confirm its status
Vandoeuvre Les NancyFranceRecruiting
VU University Medical Centre
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
University Medical Center Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.