HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
NCT ID: NCT05373264
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2024-03-31
2029-07-31
Brief Summary
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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.
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Detailed Description
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Study design: Investigator driven randomized placebo-controlled multicenter trial
Study population: 300 ADPKD patients of ≥18 years, with an eGFR of \> 25 mL/min/1.73m2, on stable treatment with the highest tolerated dose of V2RA
Intervention: Oral HCT 25 mg once daily or matching placebo for a total of 156 weeks. The randomization ratio will be 1:1.
Study visit schedule: study measurements will be performed during 12-weekly visits (which is routine care for V2RA treated patients), except for one additional study visit (or telephone call) 2 weeks after the start of treatment
Primary study outcome: Slope of kidney function decline (measured by eGFR)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hydrochlorothiazide
Oral hydrochlorothiazide 25mg, once daily, for a total of 156 weeks
Hydrochlorothiazide 25 mg
An oral capsule containing 25mg of hydrochlorothiazide
Placebo
Matching oral placebo, once daily, for a total of 156 weeks. The placebo is inert.
Placebo
A matching oral capsule containing placebo
Interventions
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Hydrochlorothiazide 25 mg
An oral capsule containing 25mg of hydrochlorothiazide
Placebo
A matching oral capsule containing placebo
Eligibility Criteria
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Inclusion 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
* Use of any diuretic
* Orthostatic hypotension complaints or blood pressure \<105/65mmHg during screening visit
* Uncontrolled hypertension (blood pressure \>160/100mmHg)
* Hypokalemia (\<3.5 mmol/L)
* 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)
18 Years
80 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Ron Gansevoort
Prof. dr.
Principal Investigators
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Prof. dr. R.T. Gansevoort
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
University Hospital Leuven
Leuven, , Belgium
Hospital La Cavale Blanche
Brest, , France
Necker-Enfants Malades Hospital
Paris, , France
Charité University Hospital
Berlin, , Germany
University Hospital Cologne
Cologne, , Germany
Med. Klinik und Poliklinik III, Universitätsklinikum Dresden.
Dresden, , Germany
Amsterdam University Medical Center
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Fundación Puigvert
Barcelona, , Spain
Addenbrooke's Hospital
Cambridge, , United Kingdom
University of Sheffield Medical School
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Prof. Nathalie Demoulin
Role: primary
Alexander Paliege
Role: primary
Other Identifiers
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2021-005612-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
202100714
Identifier Type: -
Identifier Source: org_study_id
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