Tolvaptan for nephrogenic diabetes insipidus

Phase 1

Recruiting

• Conditions: ephrogenic diabetes insipidus; Nephrogenic diabetes insipidus, polyuria; D018500

• Registration Number: JPRN-jRCTs031180369
• Lead Sponsor: Makita Noriko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1) > 20 y.o. or 20 y.o.
2) nephrogenic diabetes insipidus caused by mutations in AVPR2
3) Principal or sub investigators judge
4) Written informed consent

Exclusion Criteria

1) Allergic reactions against tolvaptan
2) Pregnant, unwilling to practice contraception during the study, or lactating female
3) < eGFR 30 mL/min/1.73m2
4) AST > 99 IU/L or ALT > 99 IU/L
5) congestive heart failure
6) active tuberculosis
7) alcohol abuse or drug abuse
8) participate in other studies with drug use within 4 months (if patch test, within 1 month)
9) blood sampling or donation 200 mL within 2 weeks, 400 mL within 12 weeks, or component blood sampling or donation within 12 weeks
10) Principal or sub investigators judge

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rine volume

Secondary Outcome Measures

Name	Time	Method
1) Urine osmolarity, urine specific gravity, amount of drinking, aquaporin-2 in urine<br>2) safety