Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study
NCT ID: NCT03202667
Last Updated: 2021-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
17 participants
INTERVENTIONAL
2017-12-15
2021-12-06
Brief Summary
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Especially chronic (\>72h) SIADH is difficult to treat as standard therapeutic options (water restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making additional therapy necessary.
Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with chronic SIADH, as it resembles the aquaretic effect of urea.
The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium levels of patients with chronic SIADH.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin
Treatment with empagliflozin 25mg tablets once daily for 28 days
Empagliflozin 25mg
Treatment with empagliflozin 25mg once daily for 28 days
Placebo
Treatment with Placebo tablets once daily for 28 days
Placebo
Treatment with Placebo oral tablet once daily for 28 days
Interventions
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Empagliflozin 25mg
Treatment with empagliflozin 25mg once daily for 28 days
Placebo
Treatment with Placebo oral tablet once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* serum osmolality \<275mosm/kg
* urine osmolality \>100mosm/kg
* urine sodium \>30mmol/l
Exclusion Criteria
* severe symptomatic hyponatremia in need of hospital treatment
* diabetes mellitus type 1
* uncontrolled hypothyroidism
* uncontrolled adrenal insufficiency
* renal impairment (GFR \<45ml/min)
* cardiac failure
* symptomatic liver disease / severe hepatic impairment (ALAT / aspartate transaminase (ASAT) \> 3x upper limit)
* treatment with SGLT 2 inhibitors, lithium chloride, urea or glitazone
* severe immunosuppression
* pregnancy or breastfeeding
* palliative situation (end of life care)
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Mirjam Christ-Crain, Prof. Dr. MD
Role: STUDY_DIRECTOR
University Hopsital Basel
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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References
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Monnerat S, Refardt J, Potasso L, Meier C, Christ-Crain M. An Increase in Plasma Sodium Levels Is Associated With an Increase in Osteoblast Function in Chronic SIAD. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1027-e1033. doi: 10.1210/clinem/dgad238.
Refardt J, Imber C, Nobbenhuis R, Sailer CO, Haslbauer A, Monnerat S, Bathelt C, Vogt DR, Berres M, Winzeler B, Bridenbaugh SA, Christ-Crain M. Treatment Effect of the SGLT2 Inhibitor Empagliflozin on Chronic Syndrome of Inappropriate Antidiuresis: Results of a Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. J Am Soc Nephrol. 2023 Feb 1;34(2):322-332. doi: 10.1681/ASN.2022050623. Epub 2022 Nov 17.
Other Identifiers
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2017-00701
Identifier Type: -
Identifier Source: org_study_id