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NOT YET RECRUITING
NCT07828002
PHASE2/PHASE3

The GranStone Trial

Sponsor: Martin Blomberg Jensen

View on ClinicalTrials.gov

Summary

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.

Official title: Prevention of Kidney Stones Due to Paraffin Oil Induced Granuloma: A Prospective Interventional Study

Key Details

Gender

MALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09

Completion Date

2029-04

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

empagliflozin (Jardiance) 25 mg

Once daily 25 mg tablet PO

DRUG

Losartan 100 mg

Once daily 100 mg tablet PO

Locations (1)

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

Herlev, Denmark