HyponatremiaSAMPLENCT02545101

An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH

An observational study of Hyponatremia and Syndrome of Inappropriate ADH (SIADH) Secretion, run by Otsuka Pharmaceutical Europe Ltd at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
How many people: 100 participants
Where: 7 sitesin 2 countries
Study dates: Nov 2015to Apr 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Eligible patients are ≥ 18 years old and have been treated with at least 2 doses of tolvaptan for one occurrence of hyponatraemia secondary to SIADH during 2014. If the number of patients treated with tolvaptan in 2014 in the participating centres is not sufficient to reach the intended sample size, this retrospective enrolment period could be extended to include patients treated in 2013. A mix of centres and treating departments (e.g. endocrinology, nephrology, etc.), will be selected within each participating country in order to provide a sufficiently representative sample of patients treated with tolvaptan for hyponatraemia secondary to SIADH.

Who may be able to join

Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable.
Female and/or male patients aged 18 years and over.
Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.

Who cannot join

A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

Germany4 sites

Study site
Bochum
Study site
Chemnitz
Study site
Dresden
Study site
Lübeck

Other trials in Germany

Spain3 sites

Study site
Córdoba
Study site
Madrid
Study site
Santiago de Compostela

Other trials in Spain

About this study

Official title: A Non Interventional, Retrospective Study on Real World Usage and Treatment Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to the SIADH.

Conditions: Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
Keywords: Hyponatremia due to SIADH, tolvaptan
Medical subject headings: Hyponatremia, Inappropriate ADH Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).
Measured: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)

Secondary outcomes (10)

Change in Sodium Levels 24 Hours After Treatment Initiation
Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan
Measured: From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards
Change in Sodium Levels 6 Weeks After Treatment Initiation
Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6
Measured: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Time (Hours) to Sodium Normalisation
Time (hours) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).
Measured: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)
Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Measured: Baseline
Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)
symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Measured: Baseline
Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)
specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records
Measured: Baseline
Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study
Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).
For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).
Measured: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Time (Days) to Sodium Normalisation
Time (days) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).
Measured: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia
symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Measured: Baseline
Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study
Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).
For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).
Measured: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Apr 2016

First posted9 Sep 2015 (estimated)
Study startNov 2015
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HyponatremiaStudies of the same condition, open and under way.
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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02545101
Sponsor's protocol ID: 156-303-00034
Acronym: SAMPLE
Status last verified: Feb 2018
First submitted: 7 Sep 2015
Last updated: 7 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pose-Reino A, Runkle de la Vega I, de Jong-Laird A, Kabra M, Lindner U. Real-World, Non-Interventional, Retrospective Study (SAMPLE) of Tolvaptan in Patients with Hyponatraemia Secondary to the Syndrome of Inappropriate Antidiuretic Hormone Secretion. Adv Ther. 2021 Feb;38(2):1055-1067. doi: 10.1007/s12325-020-01560-2. Epub 2020 Dec 11.
PubMed 33306187

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome
Recruiting
Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Thiazide Associated Hyponatremia

All Hyponatremia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non Interventional, Retrospective Study on Real World Usage and Treatment Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to the SIADH.
ClinicalTrials.gov ID: NCT02545101
Acronym / sponsor ID: SAMPLE / 156-303-00034
Conditions: Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
Keywords: Hyponatremia due to SIADH, tolvaptan
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 9 Sep 2015 (estimated)
Results: Posted 5 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Eligible patients are ≥ 18 years old and have been treated with at least 2 doses of tolvaptan for one occurrence of hyponatraemia secondary to SIADH during 2014. If the number of patients treated with tolvaptan in 2014 in the participating centres is not sufficient to reach the intended sample size, this retrospective enrolment period could be extended to include patients treated in 2013. A mix of centres and treating departments (e.g. endocrinology, nephrology, etc.), will be selected within each participating country in order to provide a sufficiently representative sample of patients treated with tolvaptan for hyponatraemia secondary to SIADH.

Key inclusion criteria (3 listed)

Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable.
Female and/or male patients aged 18 years and over.
Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.

Key exclusion criteria (1 listed)

A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
Time frame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)
The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).

10 secondary outcomes

Change in Sodium Levels 24 Hours After Treatment Initiation
Time frame: From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards
Change in Sodium Levels 6 Weeks After Treatment Initiation
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Time (Hours) to Sodium Normalisation
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)
Time frame: Baseline
Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)
Time frame: Baseline
Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)
Time frame: Baseline
Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Time (Days) to Sodium Normalisation
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia
Time frame: Baseline
Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

Results and safety

Results posted to the registry on 5 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tolvaptan	100	100

Primary outcome: Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge

Time frame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment). Mean (Standard Deviation). Unit: mmol/L

Measure	Tolvaptan n = 96
Value	10.3 (6.42)

Population analysed: Baseline sodium level was not available for 4 patients

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study period was defined for each patient as: from start of tolvaptan treatment until 6 weeks afterwards maximum.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tolvaptan	10 of 100 (10%)	12 of 100 (12%)	3 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33306187Pose-Reino A, Runkle de la Vega I, de Jong-Laird A, Kabra M, Lindner U. Real-World, Non-Interventional, Retrospective Study (SAMPLE) of Tolvaptan in Patients with Hyponatraemia Secondary to the Syndrome of Inappropriate Antidiuretic Hormone Secretion. Adv Ther. 2021 Feb;38(2):1055-1067. doi: 10.1007/s12325-020-01560-2. Epub 2020 Dec 11.

Related trials for Hyponatremia

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome
Recruiting
Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Thiazide Associated Hyponatremia

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.

Medical Department study director

Otsuka Europe

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hyponatremia and Syndrome of Inappropriate ADH (SIADH) Secretion, run by Otsuka Pharmaceutical Europe Ltd at 7 sites in 2 countries.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Spain. 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?

Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge (time frame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02545101, which also lists 1 linked publication.

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 7 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.