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Diuretic

Hydrochlorothiazide for Polycystic Kidney Disease (HYDRO-PROTECT Trial)

Phase 3
Waitlist Available
Led By Prof. dr. R.T. Gansevoort
Research Sponsored by University Medical Center Groningen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months
ADPKD diagnosis (modified Ravine criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 168 weeks
Awards & highlights

HYDRO-PROTECT Trial Summary

This trial will test whether a V2R antagonist, tolvaptan, can be more effective in treating ADPKD when co-administered with hydrochlorothiazide.

Who is the study for?
This trial is for adults over 18 with Polycystic Kidney Disease (ADPKD) who have a certain level of kidney function and have been on Tolvaptan treatment. It's not for those allergic to Hydrochlorothiazide, using other diuretics, with very low or high blood pressure, low potassium levels, frequent gout attacks, or a history of skin cancer.Check my eligibility
What is being tested?
The study tests if adding Hydrochlorothiazide to the current ADPKD treatment with Tolvaptan can better slow down kidney decline and improve life quality. About 300 patients will either receive the drug or a placebo in addition to their standard care.See study design
What are the potential side effects?
Hydrochlorothiazide may cause dehydration effects like increased urination, dizziness due to low blood pressure, electrolyte imbalances such as low potassium which could affect heart rhythm and muscle function.

HYDRO-PROTECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of my heart medication for at least 3 months.
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I have been diagnosed with ADPKD.
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I am 18 years old or older.

HYDRO-PROTECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~168 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in kidney function decline
Secondary outcome measures
Change in V2RA discontinuation rate
Change in V2RA dose
Changes in 24-hour urine volume
+11 more

HYDRO-PROTECT Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: HydrochlorothiazideActive Control1 Intervention
Oral hydrochlorothiazide 25mg, once daily, for a total of 156 weeks
Group II: PlaceboPlacebo Group1 Intervention
Matching oral placebo, once daily, for a total of 156 weeks. The placebo is inert.

Find a Location

Who is running the clinical trial?

University Medical Center GroningenLead Sponsor
703 Previous Clinical Trials
655,158 Total Patients Enrolled
Prof. dr. R.T. GansevoortPrincipal InvestigatorUniversity Medical Center Groningen

Media Library

Hydrochlorothiazide (Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05373264 — Phase 3
Polycystic Kidney Disease Research Study Groups: Hydrochlorothiazide, Placebo
Polycystic Kidney Disease Clinical Trial 2023: Hydrochlorothiazide Highlights & Side Effects. Trial Name: NCT05373264 — Phase 3
Hydrochlorothiazide (Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373264 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there long-term repercussions to taking Hydrochlorothiazide?

"Hydrochlorothiazide has received a safety score of 3 from our analysts at Power. This is due to the fact that it is a Phase 3 trial, and thus has both evidence of efficacy and multiple rounds of safety data."

Answered by AI

Which type of patient do you think would respond best to this treatment?

"This study is for adults aged 18-80 who have been diagnosed with kidney disease. They are looking to enroll 300 total participants."

Answered by AI

Are people with the necessary qualifications currently able to enroll in this clinical trial?

"No, this research is not presently looking for volunteers. However, this may change in the future as the study was last updated on May 10th, 2022. Additionally, there are 499 other trials that are currently enrolling patients."

Answered by AI

Does this research allow for volunteers who are older than 55 years of age?

"Patients that meet the age requirement of 18-80 years old are eligible for this clinical trial. There are 43 other trials for patients that are younger and 458 for seniors."

Answered by AI
~200 spots leftby Jul 2028