WithdrawnPhase 3

A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia

Stopped: Trial withdrawn due to inability to meet the trial objectives (Pilot).

0Started 2015-11

Plain-language summary

The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent subjects with euvolemic or hypervolemic hyponatremia.

Who can participate

Age range4 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female subjects ≥ 4 years of age (or per local Health Authority age restriction) to \< 18 years old and ≥ 10kg
✓. Subjects hospitalized with euvolemic or hypervolemic hyponatremia resistant to initial standard background therapy (including fluid restriction and excluding a vasopressin antagonist) and who are deemed by the investigator as likely to benefit from a therapy that raises serum sodium levels
✓. Persistent euvolemic or hypervolemic hyponatremia defined as being documented as present for at least 48 hours, evidenced by at least 2 serum sodium assessments \< 130 mmol/L drawn at least 12 hours apart (these values can be documented using historical values previously obtained per standard of care); a third (STAT) serum sodium assessment \< 130 mmol/L, which will serve as the baseline value for efficacy endpoints, is to be obtained within 2-4 hours prior to the final trial qualification and the first dose of IMP
✓. Ability to swallow tablets
✓. Ability to maintain adequate fluid intake whether orally or via IV support with adequate monitoring
✓. Ability to comply with all requirements of the trial
✓. Trial-specific written informed consent/assent obtained from a parent/legal guardian or legally acceptable representative, as applicable per age of subject or local laws, prior to the initiation of any protocol required procedures. In addition, the subject as required by local laws must provide informed assent at Screening and must be able to understand that he or she can withdraw from the trial at any time.
✓. Ability to commit to remain fully abstinent (periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] or withdrawal are not acceptable methods of contraception) or practice double-barrier birth control during the trial and for 30 days following the last dose of IMP for sexually active females of childbearing potential

Exclusion criteria

✕. Has evidence of hypovolemia or intravascular volume depletion (eg, hypotension, clinical evidence of volume depletion, response to saline challenge); if the subject has systolic blood pressure or heart rate outside of the normal range for that age volume status should be specifically clinically assessed to rule out volume depletion
✕. Has serum sodium \< 120 mmol/L, with or without associated neurologic impairment (ie, symptoms such as apathy, confusion, or seizures)
✕. Subjects ≤ 50 kg taking potent CYP3A4 inhibitors or subjects \< 20 kg taking moderate CYP3A4 inhibitors within 72 hours prior to dosing
✕. Lacks free access to water (inability to respond to thirst) or without ICU-level fluid monitoring and management
✕. Has a history or current diagnosis of nephrotic syndrome
✕. Has transient hyponatremia likely to resolve (eg, head trauma or post-operative state)
✕. Has hyperkalemia defined as serum potassium above the ULN for the appropriate pediatric age range
✕. Has eGFR \< 30 mL/min/1.73 m2 calculated by the following equation:

What they're measuring

Change in serum sodium concentration

Timeframe: Daily up to day 4

Trial details

NCT IDNCT02442674

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-22

View on ClinicalTrials.gov More Hyponatremia trials