Two common drugs put to the test against kidney stones caused by cosmetic paraffin injections
NCT ID NCT07828002
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Paraffin disease happens when people inject paraffin oil into muscle for cosmetic enlargement, causing chronic inflammation, high blood calcium, kidney stones, and kidney damage. Researchers are testing whether empagliflozin or losartan, two drugs already used for kidney protection in other conditions, can prevent new kidney stones or slow kidney problems in men with this disease. The trial assigns about 100 men to one of the treatments and tracks them for up to two years with scans and blood tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin and losartan
- What this could lead to
- If either drug works, it could offer a way to prevent kidney stones and protect kidney function in people with paraffin disease, without relying on high-dose steroids.
- What could go wrong
- The trial is mid-stage and modest in size, so results may not hold up in larger groups. Empagliflozin and losartan carry known risks such as low blood pressure, kidney changes, or electrolyte shifts, and they may not stop stone formation in this condition.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
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 to 70 years
- Sex
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Male participants only
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent by participant * Male * 18-70 years * Paraffin granuloma disease with hypercalcemia, hypoparathyroidism, hypercalciuria or a history of nephrolithiasis Exclusion Criteria: * eGFR \< 30 ml/min * Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial * Type 1 DM * Known chronic kidney disease in whom RAS-blockade and SGLT2-inhibition is indicated. * Severely impaired liver function * History of organ transplantation * Receiving therapy with an SGLT2 inhibitor or ATII antagonist within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor or ATII antagonist. * Known history of angioedema * Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the trial, as judged by the investigator
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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
1 site. 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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Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev, Herlev
Herlev, 2730, Denmark
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