Polycystic Kidney Disease Clinical Trials

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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
University Hospital Leuven
RECRUITING
Leuven
France
Hospital La Cavale Blanche
RECRUITING
Brest
Necker-Enfants Malades Hospital
RECRUITING
Paris
Germany
Charité University Hospital
RECRUITING
Berlin
University Hospital Cologne
RECRUITING
Cologne
Med. Klinik und Poliklinik III, Universitätsklinikum Dresden.
RECRUITING
Dresden
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
University Medical Center Groningen
RECRUITING
Groningen
Erasmus University Medical Center
RECRUITING
Rotterdam
Spain
Fundación Puigvert
RECRUITING
Barcelona
La Fundación Jiménez Díaz
RECRUITING
Madrid
Contact Information
Primary
Dr. E Meijer
esther.meijer@umcg.nl
+31 50 3616161
Backup
T. Bais, MD
t.bais@umcg.nl
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2031-07
Participants
Target number of participants: 300
Treatments
Active_comparator: Hydrochlorothiazide
Oral hydrochlorothiazide 25mg, once daily, for a total of 156 weeks
Placebo_comparator: Placebo
Matching oral placebo, once daily, for a total of 156 weeks. The placebo is inert.
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov