The GranStone Trial

Sponsor
Martin Blomberg Jensen
Study ID
NCT07828002
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Granuloma, Foreign-Body
  • Paraffinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will investigate whether treatment with empagliflozin or losartan can reduce the risk of kidney stone formation in patients with paraffin disease, a condition caused by the injection of paraffin oil into muscle tissue for cosmetic muscle enlargement. Paraffin disease can lead to chronic inflammation, disturbances in calcium regulation, high blood calcium levels, kidney stones, and impaired kidney function. Previous studies from Herlev-Gentofte Hospital have shown that kidney stones occur in nearly half of affected patients, while approximately one-third develop reduced kidney function. Current treatment primarily consists of high-dose corticosteroids, which can reduce blood calcium levels but cause substantial adverse effects and may not adequately control the underlying disease process. Both empagliflozin and losartan are widely used medications with documented kidney-protective effects in other chronic kidney diseases. This randomized clinical trial will evaluate whether either treatment can prevent kidney stone formation and slow kidney-related complications in patients with paraffin disease. The purpose of this study is to determine whether treatment with empagliflozin or losartan can prevent kidney stone formation and improve kidney health in patients with paraffin disease.

Key Dates

First listed
Sep 18, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    Once daily 25 mg tablet PO
  • Active Comparator: Losartan
    Once daily 100 mg tablet PO

Primary Outcome Measure

Image verified new or increased nephrolithiasis or nephrocalcinosis (from 0-24 months). [ Time Frame: From baseline to end of follow-up at 24 months ]

Central Contacts