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HYDROchlorothiazide to PROTECT polycystic kidney disease patients and improve their quality of life (HYDRO-PROTECT)
EU CTIS ID: 2022-500210-26-00
What this study is testing
Autosomal Dominant Polycystic Kidney Disease (ADPKD) leads to progressive renal cyst formation and loss of kidney function in most patients. Vasopressin 2 receptor antagonists (V2RA) like tolvaptan are currently the only available renoprotective treatment for ADPKD. However, aquaretic side effects substantially limit their tolerability and therapeutic potential. In a small scale clinical study, addition of hydrochlorothiazide (HCT) to tolvaptan decreased 24-hour urinary volume and potentially increased renoprotective efficacy. The HYDRO-PROTECT study will investigate the long-term effect of co-treatment with HCT on tolvaptan efficacy (rate of kidney function decline) and tolerability (aquaresis and quality of life) in ADPKD patients. The primary study outcome is the rate of kidney function decline (expressed as eGFR slope, in mL/min/1.73m2 per year) in HCT versus placebo treated patients, calculated by linear mixed model analysis using all available creatinine values from week 12 until end of treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) ADPKD diagnosis (modified Ravine criteria) 2 ≥18 years old 3) eGFR > 25 mL/min/1.73m2 (in Belgium eGFR > 35 mL/min/1.73m2) 4) On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months
You likely can't join if
- 1) Known intolerance to hydrochlorothiazide 2) Use of any diuretic 3) Changes in antihypertensive treatment in the last month 4) Orthostatic hypotension or blood pressure < 105/65 mmHg 5) Uncontrolled hypertension (blood pressure >160/100mmHg) 6) Hypokalemia (<3.5 mmol/L) 7) Diabetes mellitus type 1 or type 2 8) Primary renal disease other than ADPKD 9) History of active gout despite maintenance preventive treatment for gout (allopurinol, desuric, febuxostat and/or colchicine), defined as ≥2 episodes during the last year 10) History of skin cancer (basal cell, squamous cell and melanoma) 11) Anuria 12) Severe liver function impairment 13) Hypercalcemia 14) Salt losing nephropathy 15) Pregnancy 16) Breast feeding 17) Concurrent use of any medications listed under 8.1.2 18) Not able to give informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.