AuthorisedPhase II and Phase III (Integrated)Interventional

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

The GranStone Trial is a research study investigating how to prevent kidney stones in men diagnosed with Paraffin Oil Induced Granulomatous Disease. This condition can lead to kidney stone formation, and this trial aims to find effective ways to stop or slow this process. Researchers are testing two medications, Empagliflozin and Losartan, to see if they can prevent new kidney stones from appearing or if they can prevent existing ones from growing worse. The study will monitor participants for 1 to 24 months, using scans to check for changes in kidney stones. They will also look at various health markers like kidney function and overall well-being. This is an important step towards finding better treatments for this specific group of patients.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Region Hovedstaden

Enrolment target

100

Start

11 May 2026

Paraffin Oil Induced Granulomatous Disease

What is this study about?

The GranStone Trial is a study focused on a condition called Paraffin Oil Induced Granulomatous Disease. People with this condition can sometimes develop painful kidney stones. This trial aims to find out if certain medications can help stop these kidney stones from forming or getting bigger. Currently, there isn't a specific treatment to prevent these stones in this patient group, so finding an effective approach would be a big step forward.

The researchers are testing two existing medications: Empagliflozin and Losartan. These medicines are already used for other purposes, but this study investigates if they can also help prevent kidney stones in this specific situation. They will closely watch how patients' kidneys are doing by taking regular scans and measuring various health markers.

Over the course of 1 to 24 months, doctors will be looking for any new kidney stones or if existing ones have grown. They will also be checking other aspects of health, like kidney function, calcium levels, and even heart health, to understand the full picture of how these medications might affect patients. This careful monitoring will help them understand if these treatments are safe and effective.

Key takeaways

This study aims to prevent kidney stones in men with Paraffin Oil Induced Granulomatous Disease.
It is testing two existing medications, Empagliflozin and Losartan.
Participation could last up to two years and involves regular health checks and scans.
The goal is to find new ways to stop kidney stones from forming or getting worse.
Only men aged 18 and over, with this specific condition and recent kidney stone activity, can join.

Who may be eligible?

To be part of this study, you need to be an adult man, 18 years old or older. There isn't an upper age limit, meaning men of any adult age can take part.

You must have a diagnosis of Paraffin Oil Induced Granulomatous Disease. The study will be specifically looking at patients who have recently been diagnosed with new kidney stones, or whose existing kidney stones have shown signs of getting bigger, as seen on medical scans within the last 1 to 24 months. This means the study is looking for men who are actively experiencing or at high risk of kidney stone progression due to their underlying condition.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Are you 18 years old or older?
Do you have a diagnosis of Paraffin Oil Induced Granulomatous Disease?
Have medical scans shown new or growing kidney stones within the last 1 to 24 months?

Answer every question to see your result.

What does participation involve?

If you decide to participate in the GranStone Trial, you would likely have several visits to the study clinic over a period of 1 to 24 months. At these visits, you would receive either one of the study medications (Empagliflozin or Losartan) or a dummy pill (placebo). You would undergo regular medical assessments, including scans to check for kidney stones, blood and urine tests to monitor various health markers, and potentially heart health checks like echocardiograms. You might also be asked to complete questionnaires about your general health and well-being. The total duration of your involvement could be up to two years, depending on the study design for your specific part.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a medication that could help prevent kidney stones related to your condition. However, there's also a chance you might receive a placebo without active medicine. As with any medication, there are potential side effects, and the study team will explain these to you in detail. All procedures carry some risks, which will be carefully managed. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Denmark

Common questions

What exactly is Paraffin Oil Induced Granulomatous Disease?

It's a condition where, due to exposure to paraffin oil, your body develops small clumps of immune cells (granulomas), which can sometimes lead to complications like kidney stones.

Why are they studying kidney stones?

Kidney stones can be very painful and cause serious health problems. This study is looking for ways to prevent them in men who have Paraffin Oil Induced Granulomatous Disease.

What are Empagliflozin and Losartan?

These are medicines that are already used to treat other health conditions. Researchers are now investigating if they can also help prevent kidney stones in this specific situation.

Will I definitely get one of the new medications?

In a study like this, participants are usually given either the study medicine or a dummy pill (placebo). This helps researchers find out if the medicine is truly effective.

How long will I be in the study?

Your involvement in the study could last anywhere from one month up to two years, depending on the specific part of the study you join.