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The GranStone Trial

StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07828002
Lead Sponsor Martin Blomberg Jensen
Collaborators: Copenhagen University Hospital at Herlev
Conditions
(from sponsor)
Paraffinoma, Granuloma, Foreign-Body
Related terms Granuloma, Foreign-Body, Hypercalcemia, Nephrocalcinosis, Nephrolithiasis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov