Losartan potassium; Hydrochlorothiazide for Paraffin oil-induced granulomatous disease | Nephrolithiasis

Inclusion criteria

• {"criterion_text":"- Signed informed consent by participant\n- Male\n- 18-70 years\n- Paraffin granuloma disease with hypercalcemia, hypoparathyroidism, hypercalciuria or a history of nephrolithiasis"}

Exclusion criteria

• {"criterion_text":"- eGFR < 20 ml/min\n- Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator’s opinion could interfere with the results of the trial\n- Type 1 DM\n- Known autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis\n- History of organ transplantation\n- Receiving therapy with an SGLT2 inhibitor or ATII antagonist within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor or ATII antagonist.\n- Known history of angioedema\n- Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the trial, as judged by the investigator"}

Primary endpoints

• {"endpoint_text":"- Image verified new or increased nephrolithiasis or nephrocalcinosis (from 1-24 months).","definition_or_measurement_approach":"Imaging-verified occurrence or increase in nephrolithiasis or nephrocalcinosis assessed during months 1–24."}

Secondary endpoints

• {"endpoint_text":"- Change in estimated glomerular filtration rate (eGFR).","definition_or_measurement_approach":"Change in eGFR over study follow-up."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in specified serum and urine calcium-related measures at 12 and 24 months (p-Calcium ion, p-PTH, urine calcium excretion) as defined."}
• {"endpoint_text":"- Change in average daily prednisolone dosage based on cumulative average predniso-lone dose.","definition_or_measurement_approach":"Change in average daily prednisolone dose calculated from cumulative average prednisolone exposure."}
• {"endpoint_text":"- Change in p-creatinine, eGFR and BUN.","definition_or_measurement_approach":"Changes in laboratory measures p-creatinine, eGFR and BUN over time."}
• {"endpoint_text":"- Change in p-IL-2R and/or p-ACE.","definition_or_measurement_approach":"Changes in plasma IL-2 receptor and/or plasma ACE levels."}
• {"endpoint_text":"- Change in physical- and mental health scores (SF-36).","definition_or_measurement_approach":"Change in SF-36 physical and mental component scores."}
• {"endpoint_text":"- Change in mineral homeostasis in serum and urine (albumin, phosphate, magnesium, iron, ferritin, FGF23, Klotho).","definition_or_measurement_approach":"Changes in listed serum and urine mineral/metabolic biomarkers."}
• {"endpoint_text":"- Changes in serum vitamin D metabolites (25OHD,24,25(OH)2D3, 1,25(OH)2D).","definition_or_measurement_approach":"Changes in specified vitamin D metabolites in serum."}
• {"endpoint_text":"- Change in urine Na, Ka, pH, citrate, oxalate, bicarbonate, uric acid, urea.","definition_or_measurement_approach":"Changes in listed urine analytes and parameters."}
• {"endpoint_text":"- Changes in left ventricular ejection fraction (LVEF) and other indices of cardiac function as measured by transthoracic echocardiography.","definition_or_measurement_approach":"Echocardiographic assessment of LVEF and other cardiac function indices."}
• {"endpoint_text":"- Incident or worsening signs of: Systolic- and/or diastolic dysfunction, left ventricular hypertrophy, structural heart disease including valvular pathology.","definition_or_measurement_approach":"Incidence or progression of listed cardiac conditions/signs identified during assessments."}
• {"endpoint_text":"- Changes in CT Hounsfield Units in the femoral neck and lumbar vertebrae.","definition_or_measurement_approach":"Changes in CT Hounsfield Units measured at femoral neck and lumbar vertebrae."}
• {"endpoint_text":"- Changes Coronary Artery Calcium Score on CT-scan.","definition_or_measurement_approach":"Change in coronary artery calcium score measured by CT."}
• {"endpoint_text":"- Change in BMD, fat- and lean mass evaluated by DXA-scan.","definition_or_measurement_approach":"DXA-derived changes in bone mineral density, fat mass and lean mass."}
• {"endpoint_text":"- Changes in self-reported kidney stones","definition_or_measurement_approach":"Self-reported occurrence or changes in kidney stone symptoms/events."}

Denmark

Earliest CTIS Part Ii Submission Date

08-05-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

3

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}