The GranStone Trial
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18-70
SponsorMartin Blomberg Jensen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent by participant
Male
18-70 years
Paraffin granuloma disease with hypercalcemia, hypoparathyroidism, hypercalciuria or a history of nephrolithiasis
Disqualifiers
eGFR < 30 ml/min
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
Type 1 DM
Known chronic kidney disease in whom RAS-blockade and SGLT2-inhibition is indicated.
Trial design
Design model
Parallel
Treatments tested in this trial
empagliflozin (Jardiance) 25 mg
DrugOnce daily 25 mg tablet PO
Losartan 100 mg
DrugOnce daily 100 mg tablet PO
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: EmpagliflozinExperimental treatment 1 intervention
Group B: LosartanActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Image verified new or increased nephrolithiasis or nephrocalcinosis (from 0-24 months).
The individual components of the composite outcome are defined as follows: * If nephrolithiasis- or nephrocalcinosis burden occurs after baseline or aggravates by more than 20% at follow-up it is counted as a positive outcome. * Any CT scans conducted as a part of a participant's routine medical care or hospital visits will also be used. * In the event that a participant undergoes more than 1 CT scan, it will be counted as a positive outcome if any of the scans shows nephrolithiasis or nephrocalcinosis accord-ing to the criteria above. * Symptomatic kidney stone as defined as visible passage of a stone in the urine accom-panied by flank/groin/abdominal pain will also be counted as a positive outcome.
Time frame
From baseline to end of follow-up at 24 monthsSecondary outcomes
1
Change in calcium homeostasis after 12 and 24 months
Change in calcium homeostasis after 12 and 24 months defined by either: 1A Change in p-Calcium ion concentration (mmol/L); 1B Change in p-PTH concen-tration (pmol/L); 1C Change in urine calcium excretion (mmol/L).
Time frame
From baseline to month 3, 12 and end of follow-up at 24 months2
Change in estimated glomerular filtration rate (eGFR) (mL/min/1.73 m²)
Time frame
From baseline to month 3, 12 and end of follow-up at 24 months3
Change in p-Creatinine (μmol/L)
Time frame
From baseline to month 3, 12 and end of follow-up at 24 months4
Change in average daily prednisolone dosage (mg) based on cumulative average prednisolone dose.
Time frame
From baseline to month 3, 12 and end of follow-up at 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Martin Blomberg Jensen
Lead sponsor
Copenhagen University Hospital at Herlev
Sponsor institution
Copenhagen University Hospital at Herlev
Collaborator
Source ClinicalTrials.gov
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