Hydrochlorothiazide for Polycystic Kidney Disease

(HYDRO-PROTECT Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen by Prof. dr. R.T. Gansevoort

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University Medical Center Groningen

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if adding hydrochlorothiazide, a common blood pressure medication, to the existing kidney disease treatment Tolvaptan can improve its effectiveness and reduce side effects. The study targets adults with a specific type of kidney disease who are already on Tolvaptan. Tolvaptan helps slow kidney damage but can cause excessive urination, and hydrochlorothiazide might help manage this issue. Tolvaptan is the only approved drug for this type of kidney disease and has been shown to slow its progression.

Eligibility Criteria

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.

Inclusion Criteria

I have been on a stable dose of my heart medication for at least 3 months.

I have been diagnosed with ADPKD.

I am 18 years old or older.

Exclusion Criteria

I have low blood pressure or feel dizzy when standing up.

I have had gout attacks more than twice last year and am on preventive medication.

My blood pressure is not higher than 160/100 mmHg.

Participant Groups

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.

Group I: Hydrochlorothiazide Active Control 1 Intervention

Oral hydrochlorothiazide 25mg, once daily, for a total of 156 weeks

Group II: Placebo Placebo Group 1 Intervention

Matching oral placebo, once daily, for a total of 156 weeks. The placebo is inert.

Hydrochlorothiazide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Hydrochlorothiazide for:

• Edema
• Hypertension
• Nephrotic syndrome
• Nephritic syndrome
• Gouty arthritis
• Calcium nephrolithiasis

🇪🇺 Approved in European Union as Hydrochlorothiazide for:

• Essential hypertension
• Oedema

🇨🇦 Approved in Canada as Hydrochlorothiazide for:

• Mild to moderate hypertension
• Edema

🇯🇵 Approved in Japan as Hydrochlorothiazide for:

• Hypertension
• Edema

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Tufts Medical Center Boston, MA

Who Is Running the Clinical Trial?

University Medical Center Groningen Lead Sponsor

References