A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene.
Not Applicable
Recruiting
- Conditions
- ephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene
- Registration Number
- JPRN-UMIN000021708
- Lead Sponsor
- Department of Nephrology and Endocrinology, The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of allergy to tolvaptan 2) Pregnant women and women suspected of being pregnant 3) Severe Renaldysfunction (eGFR < 30 mL/min/1.73m2) 4) Severe liver dysfunction (AST > 100 U/L or ALT > 100 U/L) 5) Congestive heart failure 6) Active TBc 7) Substance use disorder 8) Use of investigational drug within 4 months before participation of this study 9) Amount of whole blood sampling > 200 mL within 4 weeks, amount of whole blood sampling > 400 mL within 12 weeks, or plasmapheresis / platelet apheresis within 2 weeks. 10) Doctor's decision
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rine Volume
- Secondary Outcome Measures
Name Time Method rine Osmolarity, amount of water drinking, Urine AQP2, safety