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Two common drugs put to the test against kidney stones caused by cosmetic paraffin injections

NCT ID NCT07828002

Prevention Sponsor: Martin Blomberg Jensen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Male participants only

Healthy volunteers

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

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.

Granuloma, Foreign-Body hypercalcemia disease nephrocalcinosis nephrolithiasis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Granuloma, foreign-body Paraffinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev, Herlev

    Herlev, 2730, Denmark

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