Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Immunosuppressive drug bioequivalence in kidney transplant recipients – Prograf and CellCept

This research study is for people who have had a kidney transplant and are taking medicines called Prograf (tacrolimus) and CellCept (mycophenolate mofetil). It's comparing how similar new versions of these medicines, Tacrolimus Ascend and Mycophenolate Mofetil Accord, are to the original brands. The main goal is to check if the new versions are absorbed into the body in the same way and at similar levels as the original medicines. This is important to ensure they are just as effective at preventing your body from rejecting the new kidney. This type of study, often called a 'bioequivalence' study, helps ensure that patients receive consistent and effective treatment, regardless of the specific brand of medication they are given.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

04 Jul 2025

Organ transplantation

What is this study about?

This study is designed for individuals who have received a kidney transplant. When you have a transplant, your body’s immune system might try to reject the new organ. To prevent this, doctors prescribe medicines called immunosuppressants, which help to calm your immune system. Two common medicines for this are Prograf (containing tacrolimus) and CellCept (containing mycophenolate mofetil).

The main purpose of this research is to compare a new version of tacrolimus (called Tacrolimus Ascend) and a new version of mycophenolate mofetil (called Mycophenolate Mofetil Accord) with the original brand-name medicines, Prograf and CellCept. We want to see if the body absorbs and uses these new versions in the same way as the established ones. This process is called checking for ‘bioequivalence’ and it’s a standard way to make sure that different brands of the same medicine work equally well.

Understanding how your body handles these medicines is really important. If a new version is absorbed differently, it could affect how well it works to protect your transplanted kidney or might lead to unexpected side effects. By carefully studying this, we can be confident that all approved versions of these vital medicines are safe and effective for people like you who rely on them after a kidney transplant.

Key takeaways

This study is for kidney transplant recipients.
It compares different brands of anti-rejection medicines (Prograf/tacrolimus and CellCept/mycophenolate).
The goal is to ensure new medicine versions work as well as existing ones.
Participation involves switching medicines temporarily and providing blood/stool samples.
You will be closely monitored by a medical team.
Your decision to join or leave the study will not affect your care.

Who may be eligible?

This study is looking for volunteers who have had a kidney transplant.

To be considered for the study, you must be an adult, aged 18 years or older. The study welcomes both men and women.

Aside from your age and having had a kidney transplant, your medical team will check other details from your health records to make sure this study is suitable and safe for you. They will explain any specific health conditions or medications that might mean you can't join.

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 received a kidney transplant?
Are you currently taking anti-rejection medicines like tacrolimus (Prograf) and mycophenolate mofetil (CellCept)?
Are you able to attend regular clinic visits for blood tests and monitoring?
Are you comfortable with switching between different brands of your anti-rejection medicines during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would continue to take your usual anti-rejection medicines (Prograf/tacrolimus and CellCept/mycophenolate mofetil). Instead of your current brand, you would temporarily switch to the new versions of the medicines (Tacrolimus Ascend and Mycophenolate Mofetil Accord) for specific periods, as directed by the study team. You would attend several study visits at the clinic where doctors and nurses would take blood samples to measure how much of the medicine is in your body over time. They will also collect other samples, like stool samples, to understand more about how your body processes the medicines. You will be closely monitored throughout the study by the medical team. The total duration of your participation in the study, including all visits and follow-up, will be clearly explained to you by the study team.

Potential risks and benefits

Participating in this study might help us gain valuable information about how different versions of post-transplant medicines work, ultimately helping future patients. While there are no direct benefits to your current health, you will receive close medical monitoring throughout the study. Potential risks include those normally associated with taking blood samples, such as bruising or discomfort. There's also a chance that your body might react differently to the new versions of the medicines, though they are designed to be very similar to your usual ones. You are free to withdraw from 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
Norway

Common questions

What are Prograf and CellCept?

They are medicines commonly given after a kidney transplant to prevent your body from rejecting the new organ.

What does 'bioequivalence' mean?

It means we're checking if a new version of a medicine works just as well and is absorbed in the same way as an existing, approved version.

Will I stop taking my usual medicines?

No, you will simply switch to the new versions of these specific medicines under strict medical supervision during the study period.

Why is this study important?

It helps make sure that all available versions of important transplant medicines are safe and work effectively to protect your kidney.

Will I get paid to participate?

The study team will provide information on any compensation for your time and travel expenses.