NCT06171100

Low-dose Tolvaptan for Inpatient Hyponatraemia.

Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management. Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.

Conditions

• Hyponatremia
• SIADH

Interventions

Type	Name	Description
DRUG	Tolvaptan	Oral ingestion of low dose Tolvaptan (7.5mg daily) for management of inpatient hyponatraemia for 1st dose Tolvaptan group. Oral ingestion of low dose Tolvaptan (7.5mg daily) or standard dose Tolvaptan (15mg daily) for 2nd dose Tolvaptan group.

Timeline

• Start date: 2024-03-15
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2023-12-14
• Last updated: 2024-03-08

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study