See if empagliflozin or losartan reduce kidney stones in paraffin disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, interventional trial in adult men with paraffin granuloma and related kidney risk. Participants will receive either empagliflozin 25 mg or losartan 100 mg to see if these drugs reduce kidney stone formation and stabilize calcium balance. The study builds on prior data showing kidney problems are common in paraffin disease and that these medications may protect kidney function. Enrollment includes men aged 18–70 with specific mineral/metabolic or stone histories, and excludes those with severe kidney or liver dysfunction or prior intolerance to these drugs. Outcomes include incidence of kidney stones, calcium metabolism markers, and safety signals.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Martin B Jensen, Professor — Herlev Hospital
• Study coordinator: Martin B Jensen, Professor
• Email: martin.blomberg.jensen@regionh.dk
• Phone: +4538687318

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.