Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney disease
Phase 1
- Conditions
- Adult dominant polycystic kidney disease (ADPKD)MedDRA version: 20.0Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominantSystem Organ Class: 100000004850Therapeutic area: Body processes [G] - Physical Phenomena [G01]
- Registration Number
- EUCTR2015-001903-30-DK
- Lead Sponsor
- Department of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Age > 18 years
Diagnosis with ADPKD
Informed consent
Contraception for fertile women
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
•Renal transplantation
•Operation in the kidnety
•Diabetes mellitus
•Neoplastic conditions
•Pregnancy, nursing
•Unwillingness to participate
•eGFR > 30
•Intolerans towrds tolvaptan
•Alkohol or medical abuse,
•BP >>170/110 blodtryk despite regulation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method