Treatment of stiffness in blood vessels in patients with familial cystic kidney disease

Phase 1

Conditions: Autosomal dominant polycystic kidney disease
Therapeutic area: Not possible to specify

Registration Number: EUCTR2020-000433-40-NL

Lead Sponsor: Erasmus University Medical Centre Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

Inclusion Criteria:
• Adults with ADPKD diagnosis based on Ravine criteria and/or with PKD1 or PKD2 mutation
• CKD-EPI eGFR = 60 ml/min/1.73m2
• Ability to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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
- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main goal of this study is to determine if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD. ;Secondary Objective: The second goal is to determine whether treatment with amiloride prevents the effects of a high-salt diet.;Primary end point(s): The primary outcome of this study is a treatment group difference in non-invasively measured central PWV with or without high-salt diet.;Timepoint(s) of evaluation of this end point: At week 3, week 5 and at the end of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcomes include ambulatory (24-hour) blood pressures, markers of inflammation, salt tasting test and skin sodium content through 23Na-MRI. ;Timepoint(s) of evaluation of this end point: At week 3, week 5 and at the end of the study