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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT05373264
• Date of registration: 28/04/2022
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Groningen
• Public title: HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life HYDRO-PROTECT
• Scientific title: HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
• Date of first enrolment: March 2024
• Target sample size: 300
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05373264
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belgium, France, Germany, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: Dr. E Meijer

• Name: Prof. dr. R.T. Gansevoort
• Affiliation: University Medical Center Groningen

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

ADPKD

Intervention(s)

Drug: Hydrochlorothiazide 25 mg

Drug: Placebo

Primary Outcome(s)

Changes in kidney function decline [Time Frame: 156 weeks]

Secondary Outcome(s)

Changes in eGFR from baseline compared to end of study (12 weeks after End of Treatment) [Time Frame: 168 weeks]

Change in V2RA dose [Time Frame: 168 weeks]

Incidence of 30% decrease in eGFR, end stage kidney disease (EKSD) or renal death [Time Frame: 168 weeks]

Quality of life, assessed by the SF-12 questionnaire [Time Frame: 156 weeks]

Changes in 24-hour urine volume [Time Frame: 156 weeks]

Changes in serum sodium concentration [Time Frame: 168 weeks]

Changes in plasma serum calcium concentration [Time Frame: 168 weeks]

Changes in serum phosphate concentration [Time Frame: 168 weeks]

Quality of life, assessed by the EQ-5D questionnaire [Time Frame: 156 weeks]

Quality of life, assessed by the ADPKD-UIS questionnaire [Time Frame: 156 weeks]

Change in V2RA discontinuation rate [Time Frame: 168 weeks]

Changes in serum potassium concentration [Time Frame: 168 weeks]

Quality of life, assessed by the TIPS questionnaire [Time Frame: 156 weeks]

Incidence of (serious) adverse events [Time Frame: 168 weeks]

Secondary ID(s)

2021-005612-61

202100714

Source(s) of Monetary Support

Please refer to primary and secondary sponsors