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

To test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD Study visit schedule: study measurements will be performed during 12-weekly visits (which is routine care for V2RA treated patients), except for one additional study visit (or telephone call) 2 weeks after the start of treatment 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.

CT.gov Identifier
NCT05373264
EudraCT Identifier
2021-005612-61
CTIS:
2022-500210-26-00
Sponsor
(Other Hospital/Academic/Medical Center)
Collaborator
N/A
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Drug
Hydrochlorothiazide
See More
Tolvaptan
Genes
PKD1
GANAB
Study Dates
Jul 2024 - Nov 2030
Sex
Female & Male
Age
18 - 80 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • ADPKD diagnosis (modified Ravine criteria)
  • > or = 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 > or = 2 episodes during the last year
  • History of skin cancer (basal cell, squamous cell and melanoma)

Protocol Summary

To test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD

Study visit schedule: study measurements will be performed during 12-weekly visits (which is routine care for V2RA treated patients), except for one additional study visit (or telephone call) 2 weeks after the start of treatment

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.

Study Locations

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