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

NCT02545101 | Completed Results

• 1 other identifier: 156-303-00034
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 7

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.

Conditions

Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion

Keywords

Hyponatremia due to SIADH; tolvaptan

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards

• Change in Sodium Levels 6 Weeks After Treatment Initiation

  From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

• Time (Hours) to Sodium Normalisation

  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.,)

  Baseline

• Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)

  Baseline

Other Outcomes (2)

• Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)

  From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation

• Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)

  From 12 months up to baseline (tolvaptan treatment initiation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Europe Ltd: lead

Study Sites (7)

Unknown Facility

Bochum, Germany

Location

Unknown Facility

Chemnitz, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Lübeck, Germany

Location

Unknown Facility

Córdoba, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Related Publications (1)

• 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.

  PMID: 33306187 DERIVED

MeSH Terms

Conditions

Hyponatremia; Inappropriate ADH Syndrome

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

Results Point of Contact

• Title: Medical Department
• Organization: Otsuka Pharmaceutical Europe Ltd.

+44(0)2037475000

Study Officials

• Medical Department

  Otsuka Europe

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 9, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 7, 2018
• Results First Posted: February 5, 2018

Record last verified: 2018-02

Locations

DE (4); ES (3)