HyponatremiaNCT06171100
Low-dose Tolvaptan for Inpatient Hyponatraemia.
An observational study of Hyponatremia and SIADH, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hyponatremia, SIADH
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant women and patients aged < 18y.o
- Hyponatraemia not associated with SIADH
Trial locations and contacts
1 site in 1 country.
David Llewellyn contact
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London
Laura Freer
About this study
Official title: Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.
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
- Being tested
- Tolvaptan
- Keywords
- Tolvaptan
- Medical subject headings
- Hyponatremia, Inappropriate ADH Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| First dose tolvapatan | Not described Receives: Drug: Tolvaptan | |
| Second dose tolvaptan | Not described Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to low dose tolvaptan
Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia
Measured: Within 30 hours from tolvaptan intake
Safety of low dose tolvaptan
Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose
Measured: Within 30 hours from tolvaptan intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start15 Mar 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171100
- Sponsor's protocol ID
- GafREC: Endo205
- Status last verified
- Mar 2024
- First submitted
- 6 Dec 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.
- ClinicalTrials.gov ID
- NCT06171100
- Acronym / sponsor ID
- GafREC: Endo205
- Conditions
- Hyponatremia, SIADH
- Keywords
- Tolvaptan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First dose tolvapatan | – | Drug: Tolvaptan |
| Second dose tolvaptan | – | Drug: Tolvaptan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant women and patients aged < 18y.o
- Hyponatraemia not associated with SIADH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolvaptanOral 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. | Drug | First dose tolvapatan, Second dose tolvaptan |
Primary outcome
Response to low dose tolvaptan
Time frame: Within 30 hours from tolvaptan intake
Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia
Safety of low dose tolvaptan
Time frame: Within 30 hours from tolvaptan intake
Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Llewellyn contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and SIADH, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Dimitriadis (00441698863091, g.dimitriadis@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to low dose tolvaptan (time frame: Within 30 hours from tolvaptan intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.