Status:
COMPLETED
Treatment of Vascular Stiffness in ADPKD
Lead Sponsor:
Erasmus Medical Center
Conditions:
Autosomal Dominant Polycystic Kidney
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Objective of the study: The investigators aim to investigate if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD. The investigators also aim to explore whether treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05228574
Start Date
March 11 2022
End Date
June 18 2025
Last Update
August 17 2025
Active Locations (1)
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1
Erasmus University Medical Centre Rotterdam
Rotterdam, South Holland, Netherlands, 3015GD