Clinical trial NCT02545101: An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Syndrome of Inappropriate ADH (SIADH) Secretion
Keywords: Hyponatremia due to SIADH
tolvaptan
Lead sponsor: Otsuka Pharmaceutical Europe Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
timeFrame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)
Secondary outcomes:
measure: Change in Sodium Levels 24 Hours After Treatment Initiation
timeFrame: From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards
measure: Change in Sodium Levels 6 Weeks After Treatment Initiation
timeFrame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
measure: Time (Hours) to Sodium Normalisation
timeFrame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
measure: Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)
timeFrame: Baseline
measure: Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)
timeFrame: Baseline
measure: Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)
timeFrame: Baseline
measure: Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study
timeFrame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
measure: Time (Days) to Sodium Normalisation
timeFrame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
measure: Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia
timeFrame: Baseline
measure: Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study
timeFrame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Other outcomes:
measure: Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)
timeFrame: From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation
measure: Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)
timeFrame: From 12 months up to baseline (tolvaptan treatment initiation)
Locations:
city: Bochum
country: Germany
city: Chemnitz
country: Germany
city: Dresden
country: Germany
city: Lubeck
country: Germany
city: Córdoba
country: Spain
city: Madrid
country: Spain
city: Santiago de Compostela
country: Spain
Study officials:
affiliation: Otsuka Europe
name: Medical Department
role: STUDY_DIRECTOR
References:
citation: 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.