Hydrochlorothiazide for Kidney Diseases

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University Medical Center Groningen, Groningen, Netherlands
Kidney Diseases+2 More
Hydrochlorothiazide 25 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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 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.

Eligible Conditions

  • Kidney Diseases
  • Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: 168 weeks

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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Hydrochlorothiazide
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

300 Total Participants · 2 Treatment Groups

Primary Treatment: Hydrochlorothiazide · Has Placebo Group · Phase 3

Hydrochlorothiazide
Drug
ActiveComparator Group · 1 Intervention: Hydrochlorothiazide 25 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 168 weeks

Trial Background

Prof. Ron Gansevoort, MD
Principal Investigator
University Medical Center Groningen
Closest Location: Tufts Medical Center · Boston, MA
Photo of tufts medical center  1Photo of tufts medical center  2Photo of tufts medical center  3
2013First Recorded Clinical Trial
17 TrialsResearching Kidney Diseases
401 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years old.
You have a kidney function of at least 25 ml/min/1.73m2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.