Treatment for vascular stiffness in patients with ADPKD
Treatment of Vascular Stiffness in Patients With Autosomal Dominant Polycystic Kidney Disease
This study is testing if a medication can help people with Autosomal Dominant Polycystic Kidney Disease manage arterial stiffness caused by a high-salt diet.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South-Holland) |
| Trial ID | NCT05228574 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a high-salt diet on arterial stiffness in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Participants will follow a low-salt diet for six weeks and will be randomized to receive either sodium chloride capsules or a placebo, combined with amiloride treatment. The study aims to determine if amiloride can prevent arterial stiffness exacerbated by high salt intake. The primary outcomes will measure changes in central arterial stiffness using pulse wave velocity.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with typical ADPKD and an estimated glomerular filtration rate of 60 ml/min/1.73m2 or higher.
Not a fit: Patients with uncontrolled hypertension or those on multiple antihypertensive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment approach to manage hypertension and vascular stiffness in patients with ADPKD.
How similar studies have performed: While the approach of using amiloride in this context is novel, similar studies have explored dietary impacts on hypertension, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with typical ADPKD diagnosed based on Ravine criteria and/or a documented Pkd 1 or 2 mutation * Chronic kidney disease epidemiology collaboration equation estimated glomerular filtration rate ≥60 ml/min/1.73m2 * Ability to provide informed consent Exclusion Criteria: * Uncontrolled hypertension, defined as an office blood pressure of ≥160/ ≥90 mmHg with or without antihypertensive treatment * Concomitant use of ≥ 3 antihypertensive medications * When antihypertensive treatment is prescribed for any other treatment indication than hypertension (e.g. cardia arrhythmia) * Serum potassium levels \>5.5 mmol/L (measured within last 6 months) * History of liver disease (excluding liver cysts due to ADPKD) * History of heart failure (cardiac ejection fraction \< 35%) or cardiac arrhythmia * History of diabetes mellitus * Active infection or antibiotic therapy * Immunosuppressive therapy within the last year * Concomitant use of drugs that could influence blood pressure and/or disease progression (Tolvaptan/non-steroidal anti-inflammatory drugs (NSAIDs)/chemotherapy), excluding \< 3 antihypertensive drugs * Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study
Where this trial is running
Rotterdam, South-Holland
- Erasmus University Medical Centre Rotterdam — Rotterdam, South-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: M. Salih, MD, PhD — Erasmus Medical Center
- Study coordinator: L. Xue, MSc
- Email: l.xue@erasmusmc.nl
- Phone: (0031)107040704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.