Low-dose Tolvaptan for Inpatient Hyponatraemia.

NCT06171100 | Recruiting FDA Drug

• 1 other identifier: GafREC: Endo205
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tolvaptan

Outcome Measures

Primary Outcomes (2)

• Response to low dose tolvaptan

  Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia

  Within 30 hours from tolvaptan intake

• Safety of low dose tolvaptan

  Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose

  Within 30 hours from tolvaptan intake

Study Arms (2)

First dose tolvapatan

Drug: Tolvaptan

Second dose tolvaptan

Drug: Tolvaptan

Interventions

Tolvaptan DRUG

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.

First dose tolvapatan; Second dose tolvaptan

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to hospital through Accident \& Emergency department or those who developed inpatient moderate to severe refractory hyponatraemia associated with SIADH and needed treatment with Tolvaptan.

You may qualify if:

• All patients presenting to Accident \& Emergency department or seen as inpatients with moderate to severe hyponatraemia (sNa: \<125mmol) associated with SIADH and not responding to conservative measures of hyponatraemia management.
• Patients of all genders aged 18-90 y.o

You may not qualify if:

• Pregnant women and patients aged \< 18y.o
• Hyponatraemia not associated with SIADH

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hyponatremia; Inappropriate ADH Syndrome

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Georgios Dimitriadis

CONTACT

00441698863091; g.dimitriadis@nhs.net

David Llewellyn

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: March 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

GB (1)