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The GranStone Trial - Prevention of Kidney Stones due to Paraffin Oil Induced Granuloma

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525608-85-00
Enrollment
100
Registered
2026-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraffin Oil Induced Granulomatous Disease

Brief summary

Image verified new or increased nephrolithiasis or nephrocalcinosis (from 1-24 months).

Detailed description

Change in estimated glomerular filtration rate (eGFR)., Change in calcium homeostasis after 12 and 24 months defined by: 1A Change in p-Calcium ion concentration; 1B Change in p-PTH concentration; 1C Change in urine calcium excretion., Change in average daily prednisolone dosage based on cumulative average predniso-lone dose., Change in p-creatinine, eGFR and BUN., Change in p-IL-2R and/or p-ACE., Change in physical- and mental health scores (SF-36)., Change in mineral homeostasis in serum and urine (albumin, phosphate, magnesium, iron, ferritin, FGF23, Klotho)., Changes in serum vitamin D metabolites (25OHD,24,25(OH)2D3, 1,25(OH)2D)., Change in urine Na, Ka, pH, citrate, oxalate, bicarbonate, uric acid, urea., Changes in left ventricular ejection fraction (LVEF) and other indices of cardiac func-tion as measured by transthoracic echocardiography., Incident or worsening signs of: Systolic- and/or diastolic dysfunction, left ventricular hypertrophy, structural heart disease including valvular pathology., Changes in CT Hounsfield Units in the femoral neck and lumbar vertebrae., Changes Coronary Artery Calcium Score on CT-scan., Change in BMD, fat- and lean mass evaluated by DXA-scan., Changes in self-reported kidney stones

Interventions

DRUGEMPAGLIFLOZIN
DRUGLOSARTAN

Sponsors

Region Hovedstaden
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Image verified new or increased nephrolithiasis or nephrocalcinosis (from 1-24 months).

Secondary

MeasureTime frame
Change in estimated glomerular filtration rate (eGFR)., Change in calcium homeostasis after 12 and 24 months defined by: 1A Change in p-Calcium ion concentration; 1B Change in p-PTH concentration; 1C Change in urine calcium excretion., Change in average daily prednisolone dosage based on cumulative average predniso-lone dose., Change in p-creatinine, eGFR and BUN., Change in p-IL-2R and/or p-ACE., Change in physical- and mental health scores (SF-36)., Change in mineral homeostasis in serum and urine (albumin, phosphate, magnesium, iron, ferritin, FGF23, Klotho)., Changes in serum vitamin D metabolites (25OHD,24,25(OH)2D3, 1,25(OH)2D)., Change in urine Na, Ka, pH, citrate, oxalate, bicarbonate, uric acid, urea., Changes in left ventricular ejection fraction (LVEF) and other indices of cardiac func-tion as measured by transthoracic echocardiography., Incident or worsening signs of: Systolic- and/or diastolic dysfunction, left ventricular hypertrophy, structural heart disease including va

Outcome results

None listed

Source: EU CTIS · Data processed: May 12, 2026