Diabetes drug shows promise for dangerous low sodium condition
NCT ID NCT04447911
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether the diabetes drug empagliflozin (Jardiance) can safely raise low sodium levels in people with certain conditions like SIADH, liver failure, or kidney failure. About 172 adults with chronic low sodium will receive either the drug or a placebo for up to 30 days. The goal is to see if the drug works better than current treatments like fluid restriction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 113 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- chronic eu- OR hypervolemic non hyperosmolar (\<300 mOsm/kg) hyponatremia (heparin plasma sodium \<135 mmol/L on day of inclusion) Exclusion Criteria: * known hypersensitivity or allergy to class of drugs or the investigational product, * severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need of intensive/intermediate care treatment at time of inclusion * clinical hypovolemia * Severe reduction of eGFR \<20 mL/min/1,73 m2 (KDIGO G4 and G5) or end stage renal disease * Chronic liver insufficiency with Child Pugh Score ≥10 or decompensated liver cirrhosis (jaundice, hepatorenal syndrome, encephalopathy, bleeding, …) * Hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) \>3x the upper limit of normal (ULN); or total bilirubin \>2x ULN at time of enrolment * uncontrolled hypothyroidism * uncontrolled adrenal insufficiency * systolic blood pressure \<90mmHg * contraindication for lowering blood pressure * diabetes mellitus type 1 or pancreatic diabetes mellitus * treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day * severe immunosuppression (leucocytes \<2 G/l) * peripheral arterial disease stage III-IV of the Fontaine Classification * fasting or other reasons preventing medication intake * previous enrolment into the current study * participation in another intervention study * pregnancy, breastfeeding, intention to become pregnant during the course of the study or lack of safe contraception. * end of life care
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITINGLausanne, Canton of Vaud, 1011, Switzerland
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Erasmus Universität Medisch Centrum Rotterdam, Department of Internal Medicine
RECRUITINGRotterdam, 3015, Netherlands
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Kantonsspital Luzern
RECRUITINGLucerne, Canton of Lucerne, 6000, Switzerland
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Spitalzentrum Biel
RECRUITINGBiel, 2502, Switzerland
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University Hospital Basel
RECRUITINGBasel, 4031, Switzerland
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University Hospital of Würzburg, med. Poliklinik
RECRUITINGWürzburg, 97080, Germany
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Other studies related to the condition(s) this trial covers.
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- Can a new preservation fluid keep donor kidneys healthier for transplant?
- Extra vaccine dose: could it shield dialysis patients from hepatitis b?
- Decoding low sodium: a new tool to guide safer treatment