RecruitingPhase 3

HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life

Belgium, France, Germany300 participantsStarted 2024-07-31

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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)

What they're measuring

Changes in kidney function decline

Timeframe: 156 weeks

Trial details

NCT IDNCT05373264

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-07

Contact for this trial

Dr. E Meijer

+31 50 3616161 esther.meijer@umcg.nl