Ongoing, recruitingTherapeutic use (Phase IV)Interventional

(IPCOM) Influence of Proton pump inhibitor CO-medication on the absorption of innovator and generic formulations of Mycophenolate mofetil

This study is for people who have had organ transplants. We're investigating how taking a common medicine for stomach acid alongside mycophenolate mofetil affects how much of the mycophenolate mofetil the body absorbs. Mycophenolate mofetil is a very important medicine taken after an organ transplant to help prevent the body from rejecting the new organ. We want to see if there are any differences in absorption when people take a stomach acid reducer, specifically when they are taking the original brand of mycophenolate mofetil compared to different generic versions. The study is particularly interested in men aged 18 and over who have received an organ transplant.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

28 Feb 2025

Post Transplantation Patients

What is this study about?

When you have an organ transplant, you need to take special medicines to stop your body from rejecting the new organ. One common and very important medicine is called mycophenolate mofetil. Sometimes, transplant patients also need to take other medicines, for example, to help with stomach acid problems.

This study is looking at whether a common stomach acid medicine, called a proton pump inhibitor (PPI) like Pantoprazole, changes how your body uses mycophenolate mofetil. We want to know if taking a PPI at the same time affects how much of the mycophenolate mofetil gets into your bloodstream. This is important because if the absorption changes, it could affect how well the transplant medicine works.

The researchers are comparing three different types of mycophenolate mofetil: the original brand (CellCept) and two different generic versions (Mycophenolate Mofetil Sandoz and Mycophenolate Mofetil Accord). By doing this, they can see if there are any differences in how the branded and generic versions are absorbed when taken with a stomach acid reducer. This information helps doctors make sure patients are getting the most effective treatment after their transplant.

Key takeaways

The study explores how stomach acid medicine affects transplant medication.
It compares how well original and generic transplant medicines are absorbed.
Participation is for male transplant patients aged 18 and over.
The findings will help improve care for transplant patients.
You would attend clinic visits and provide blood samples.

Who may be eligible?

This study is looking for volunteers who have had an organ transplant. You need to be at least 18 years old to take part, and the study is specifically for men.

The researchers are interested in transplant patients who are currently taking mycophenolate mofetil and might also be taking, or start taking, a medicine for stomach acid.

More detailed information about your specific health, other medicines you take, and your transplant history would be discussed with you by the study team to see if you're a good fit.

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 18 years old or older?
Have you had an organ transplant?
Are you male?
Are you currently taking mycophenolate mofetil?
Are you willing to take specific study medications and attend clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be provided with specific medicines for the study, including different versions of mycophenolate mofetil and a stomach acid reducer (Pantoprazole Teva). You would take these medicines as instructed by the study team.

The study would involve regular visits to the clinic. During these visits, the research team would collect blood samples. These samples are important so they can measure how much of the mycophenolate mofetil is in your bloodstream at different times. This helps them understand how well your body is absorbing the medicine. The total duration of your participation would be explained in detail.

Potential risks and benefits

Participating in this study might help us learn more about how transplant medicines work, which could benefit future transplant patients. There might be some minor risks, such as discomfort from blood draws or potential side effects from the study medicines, though these medicines are commonly used. You will be closely monitored for any side effects. Remember, taking part is completely voluntary. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is mycophenolate mofetil?

It's a very important medicine given to people after an organ transplant to help stop their body from rejecting the new organ.

What is a 'proton pump inhibitor' (PPI)?

It's a type of medicine that helps reduce the amount of acid in your stomach, often used for indigestion or heartburn.

Why are you looking at different versions of the medicine?

We want to see if the original brand and various generic versions are absorbed in the same way, especially when taken with stomach acid medicine.

Will I have to fast for this study?

Specific instructions about food and drink will be given to you by the study team before any clinic visits or medication intake.

What does 'Phase IV' mean for a study?

It means the medicine is already approved and used, and researchers are gathering more information about its effects in real-world use.