Menu
Recruiting NCT05373264

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

Phase III Interventional ADPKD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrochlorothiazide 25 mg, Placebo.
Who it may be relevant to
Registry conditions: ADPKD. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France, Germany, Netherlands, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Study design: Investigator driven randomized placebo-controlled multicenter trial

Study population: 300 ADPKD patients of ≥18 years, with an eGFR of \> 25 mL/min/1.73m2, on stable treatment with the highest tolerated dose of V2RA

Intervention: Oral HCT 25 mg once daily or matching placebo for a total of 156 weeks. The randomization ratio will be 1:1.

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

Primary study outcome: Slope of kidney function decline (measured by eGFR)

Interventions

  • Drug Hydrochlorothiazide 25 mg
    An oral capsule containing 25mg of hydrochlorothiazide
  • Drug Placebo
    A matching oral capsule containing placebo

Primary outcome measures

  • Changes in kidney function decline [Time frame: 156 weeks]
Secondary outcome measures (12)
  • Changes in eGFR from baseline compared to end of study (12 weeks after End of Treatment) [Time frame: 168 weeks]
  • Incidence of 30% decrease in eGFR, end stage kidney disease (EKSD) or renal death [Time frame: 168 weeks]
  • Changes in 24-hour urine volume [Time frame: 156 weeks]
  • Quality of life, assessed by the TIPS questionnaire [Time frame: 156 weeks]
  • Quality of life, assessed by the ADPKD-UIS questionnaire [Time frame: 156 weeks]
  • Quality of life, assessed by the SF-12 questionnaire [Time frame: 156 weeks]
  • Quality of life, assessed by the EQ-5D questionnaire [Time frame: 156 weeks]
  • Change in V2RA dose [Time frame: 168 weeks]
  • Change in V2RA discontinuation rate [Time frame: 168 weeks]
  • Changes in serum sodium concentration [Time frame: 168 weeks]
  • Changes in serum potassium concentration [Time frame: 168 weeks]
  • Changes in plasma serum calcium concentration [Time frame: 168 weeks]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Germany · 3 centers
  • Charité University Hospital — Berlin
  • University Hospital Cologne — Cologne
  • Med. Klinik und Poliklinik III, Universitätsklinikum Dresden. — Dresden
Netherlands · 3 centers
  • Amsterdam University Medical Center — Amsterdam
  • University Medical Center Groningen — Groningen
  • Erasmus University Medical Center — Rotterdam
Belgium · 2 centers
  • Cliniques Universitaires Saint-Luc — Brussels
  • University Hospital Leuven — Leuven
France · 2 centers
  • Hospital La Cavale Blanche — Brest
  • Necker-Enfants Malades Hospital — Paris
Spain · 2 centers
  • Fundación Puigvert — Barcelona
  • La Fundación Jiménez Díaz — Madrid

Identifiers

NCT: NCT05373264 · 202100714 · 2021-005612-61

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗