Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene
Conditions
Interventions
1) Administration of Tolvaptan once per day (60mg/day, 90mg/day, 120mg/day), each dose for two days. 2) Administration of Tolvaptan 120mg per day for 2 to 4 weeks in outpatient.
Sponsors
Department of Nephrology and Endocrinology, The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Over 20 years old 2) Patients who have been diagnosed with nephrogenic diabetes insipidus caused by mutations in the vasorepssin type 2 receptor gene. 3) Doctor's decision based on the tests at routine outpatient visits 4) Written informed consent after a detailed explanation of this study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine Volume | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine Osmolarity, amount of water drinking, Urine AQP2, safety | — |
Countries
Japan
Contacts
Public ContactKatsunori Manaka
The University of Tokyo Hospital Nephrology and Endocrinology
Outcome results
None listed