See if empagliflozin or losartan reduce kidney stones in paraffin disease
Official title: Prevention of Kidney Stones Due to Paraffin Oil Induced Granuloma: A Prospective Interventional Study
Run by Copenhagen University Hospital at Herlev · NCT07828002 · Data updated 2026-11-12
This study tests whether empagliflozin or losartan can lower the risk of kidney stones in men with paraffin granuloma causing high calcium and kidney issues.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Men only |
| Enrollment | 100 (estimated) |
| Sponsor | Copenhagen University Hospital at Herlev Academic / other |
| Locations | 1 site (Herlev) |
| Status | Recruiting |
| Started | October 20, 2026 |
| Main results expected | March 2029 |
| Study ends | April 2029 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07828002 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 18–70 with paraffin granuloma and hypercalcemia or related kidney risk who have not had major organ transplantation and have adequate kidney function (eGFR ≥60 in most cases).
✕Probably not a fit
Patients with very reduced kidney function, certain cancers, or prior intolerance to SGLT2 inhibitors or ARBs may not benefit from this approach.
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
Potential benefit: If successful, the approach could reduce kidney stone risk and improve calcium balance in paraffin disease.
How similar studies have gone: There is limited prior evidence in paraffin disease; the concept of kidney-protective drugs has shown promise in related kidney conditions but this specific application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.