MedTrace Logo

Treatment of Vascular Stiffness in ADPKD

NCT05228574 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-08-17

No results posted yet for this study

Summary

Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited kidney disease characterized by cystic kidneys and caused by mutations in the polycystic kidney disease and other rare genes. It is associated with salt-sensitive hypertension, which accounts for the majority of morbidity and mortality. About 70% of patients with ADPKD develop hypertension, prior to the onset of kidney function decline. Early onset hypertension, despite its treatment, is independently associated with rapid kidney function decline. The investigators hypothesize that a high-sodium diet in patients with ADPKD is required for the development of vascular stiffness, which precedes hypertension, and that treatment with amiloride reverses this phenomenon.

Conditions

  • Autosomal Dominant Polycystic Kidney

Interventions

DIETARY_SUPPLEMENT

Sodium chloride (NaCl)

Sodium chloride capsules 6 grams per day for 4 weeks.

DIETARY_SUPPLEMENT

Placebo

Placebo capsules, 6 grams per day for 4 weeks.

DRUG

Amiloride Hcl 5mg Tab

Amiloride 5mg tablets, 20 mg per day for two weeks in open-label setting.

Sponsors & Collaborators

Principal Investigators

  • M. Salih, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2025-06-18
Completion
2025-06-18

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228574 on ClinicalTrials.gov