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

• Status: Not yet recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Hydrochlorothiazide

Criteria

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)