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

Condition studied

Paraffin Oil Induced Granulomatous Disease

Investigational medicinal product(s)

Every trial of Losartan and Dapagliflozin across our registers →

Eligibility

Primary endpoint

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

Endpoint detail

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