Trampoline study

Phase 1

• Conditions: Autosomal Dominant Polycystic Kidney Disease; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2024-512544-27-00
• Lead Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Adults with typical ADPKD diagnosed based on Ravine criteria and/or a documented Pkd 1 or 2 mutation, CKD-EPI eGFR =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 drugs that could influence blood pressure and/or disease progression (Tolvaptan/non-steroidal anti-inflammatory drugs (NSAIDs)/chemotherapy), excluding £ 2 antihypertensive drugs, Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified