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

Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease - TRAMPOLINE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000433-40-NL

Enrollment

Registered

2021-08-03

Start date

2021-12-30

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal dominant polycystic kidney disease

Interventions

Trade Name: Amiloride Product Name: Amiloride Pharmaceutical Form: Tablet INN or Proposed INN: AMILORIDE CAS Number: 2609-46-3 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 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

Design outcomes

Secondary

Measure	Time frame
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	—

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Contacts

Public ContactPrincipal investigator

Erasmus University Medical Centre Rotterdam

m.salih@erasmusmc.nl0031107040704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026