Study of Empagliflozin, Losartan Potassium and Hydrochlorothiazide to Prevent Kidney Stones in Patients with Paraffin Oil Induced Granulomatous Disease

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What is this study about?

The study focuses on Paraffin Oil Induced Granulomatous Disease, a rare condition in which exposure to paraffin oil causes small inflammatory nodules that can affect the kidneys and lead to the formation of kidney stones. Two oral medicines are being tested: a tablet containing empagliflozin at a dose of 25 mg and a tablet containing losartan at a dose of 100 mg, both taken once daily.

The main aim of the trial is to find out whether either medication can lower the risk of developing new kidney stones and slow the progression of the disease. Participants will be followed for up to two years, with regular clinic visits where blood and urine samples are taken and simple imaging scans are performed to look for stones and assess kidney health. One of the key laboratory measures is the eGFR, which estimates how well the kidneys are filtering waste from the blood.

During the study, researchers will compare the occurrence of kidney stones, changes in kidney function, and overall physical and mental well‑being between the groups receiving the study medicines and those receiving a placebo. The information gathered will help determine if these treatments are useful for preventing stone formation and preserving kidney health in people with this condition.

1 baseline evaluation

after joining the trial, you undergo a complete medical assessment that includes physical examination, blood sample collection, urine sample collection, and imaging of the kidneys to document any existing stones or calcifications.

the assessment also records your current medication use, dosage, and any symptoms related to paraffin oil induced granulomatous disease.

2 treatment allocation

based on the trial protocol, you are assigned to receive one of two study medicines:

empagliflozin 25 mg taken by mouth, or losartan potassium 100 mg taken by mouth (the tablet also contains hydrochlorothiazide).

the specific medicine you receive is determined by a random allocation process to ensure unbiased comparison.

3 medication administration

you begin taking the assigned tablet each day as directed by the study schedule.

the dose remains constant for the entire study period unless a protocol‑specified adjustment is required.

the medication is taken orally, and you are instructed to follow the same timing each day.

4 regular monitoring visits

throughout the 24‑month study you attend scheduled clinic visits at intervals defined by the protocol (for example, at month 1, month 3, month 6, month 12, month 18, and month 24).

at each visit you receive:

– imaging of the kidneys to check for new or enlarged kidney stones or calcium deposits.

– blood tests to measure kidney function (e.g., eGFR), calcium levels, parathyroid hormone, creatinine, BUN, and other markers listed in the secondary endpoints.

– urine tests to assess calcium excretion, pH, and other substances relevant to stone formation.

– questionnaires that evaluate physical and mental health, as well as any symptoms you notice.

5 final assessment

at the end of the 24‑month period you undergo a comprehensive evaluation that repeats the baseline imaging, blood and urine tests, and health questionnaires.

the results are used to determine whether the assigned medicine reduced the risk of kidney stones and slowed disease progression compared with the alternative treatment.

Who Can Join the Study?

Signed informed consent – you must read and sign a document that shows you understand the study and agree to take part.
Male – only men are eligible for this trial.
Age 18 to 70 years – you must be at least 18 years old and not older than 70.
Paraffin granuloma disease with one of the following conditions:
- Hypercalcemia – higher than normal calcium levels in the blood.
- Hypoparathyroidism – under‑active parathyroid glands that help control calcium.
- Hypercalciuria – higher than normal calcium levels in the urine.
- A history of nephrolithiasis – having had kidney stones in the past.

Who Cannot Join the Study?

Kidney function measured by eGFR less than 20 ml/min (eGFR is a blood test that shows how well the kidneys filter waste).
Having any current or past cancer (except for common skin cancers called basal cell or squamous cell skin cancer).
Having Type 1 diabetes mellitus (DM) (a condition where the body cannot produce insulin).
Having a known inherited kidney disease called polycystic kidney disease (whether autosomal dominant or autosomal recessive), or having kidney inflammation from lupus (lupus nephritis) or a blood‑vessel inflammation called ANCA‑associated vasculitis.
Having had an organ transplant (receiving a kidney, liver, heart, etc., from another person).
Taking or having taken within the past 8 weeks a medication known as an SGLT2 inhibitor (a drug used for diabetes) or an ATII antagonist (a drug used to lower blood pressure), or having been unable to tolerate these medicines.
Having a known history of angioedema (sudden swelling under the skin, often around the face or lips).
Being unable to understand the study, having language difficulties, having mental incapacity, or being unwilling to follow the study requirements (protocol).

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hunqnn Htfixinj	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.07.2026

Trial locations

Investigated drugs:

Empagliflozin is a medication taken by mouth that helps the kidneys remove extra sugar from the body through urine. In this trial it is being tested to see if it can lower the chance of forming kidney stones and slow down the damage caused by paraffin oil‑induced granulomas. Researchers hope that its effect on kidney function will protect patients from stone formation and disease progression.

Losartan (combined with hydrochlorothiazide) is an oral medication that lowers blood pressure and helps the body get rid of excess fluid. In the study, it is being evaluated to determine whether it can reduce the risk of kidney stones and limit the worsening of disease in people with paraffin oil‑induced granulomas. The blood‑pressure‑lowering and diuretic actions are thought to change how the kidneys handle minerals, which might prevent stone formation.

Investigated diseases:

Granulomatosis with polyangiitis

Paraffin Oil Induced Granulomatous Disease – Paraffin oil induced granulomatous disease is a condition that develops after exposure to paraffin oil, leading to the formation of small inflammatory nodules called granulomas in various tissues. The granulomas are clusters of immune cells that try to contain the oil particles. Over time, these nodules can grow and may cause thickening or scarring of the affected organs. The disease often begins with localized skin or subcutaneous lesions and can spread to deeper tissues such as lungs or kidneys. As the granulomas increase in size, they may disrupt normal tissue function and lead to symptoms like swelling or discomfort. The condition typically progresses slowly, with periods of stability alternating with gradual enlargement of the granulomas.

Trial ID:

2026-525608-85-00

Trial Phase:

Therapeutic use (Phase IV)

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Study of Empagliflozin, Losartan Potassium and Hydrochlorothiazide to Prevent Kidney Stones in Patients with Paraffin Oil Induced Granulomatous Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?