Status:
NOT_YET_RECRUITING
HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
Lead Sponsor:
University Medical Center Groningen
Conditions:
ADPKD
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 curren...
Detailed Description
Aims: The main objectives of the current study are to prospectively test whether HCT co-treatment can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in PKD....
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05373264
Start Date
March 1 2024
End Date
July 1 2029
Last Update
September 29 2023
Active Locations (13)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
2
University Hospital Leuven
Leuven, Belgium
3
Hospital La Cavale Blanche
Brest, France
4
Necker-Enfants Malades Hospital
Paris, France