Medication for excessive urine production in patients treated with tolvapta
- Conditions
- ADPKD<br />cystenieren<br />polycystic kidney disease<br />polyuria<br />polyurie<br />tolvaptan
- Registration Number
- NL-OMON25236
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Diagnosis of ADPKD, based upon modified Ravine criteria
2. Using tolvaptan 120mg daily
Exclusion Criteria
1. Patients who, in the opinion of the investigator may present a safety risk
2. Patients who are unlikely to adequately comply to the trial¡¯s procedures (due for instance to medical conditions likely to require interruption or discontinuation, history of substance abuse or non-compliance)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome variable will be change in 24-hour urine volume
- Secondary Outcome Measures
Name Time Method -Change in glomerular filtration rate (as measured with the iohexol plasma clearance technique) <br /><br> -Change in plasma copeptin <br /><br> -Tolerability of the study medication