Ongoing, recruitingTherapeutic use (Phase IV)Interventional

CALCIGRAN FORTE AND DOSING OF IMMUNOSUPPRESSIVE DRUGS IN KIDNEY TRANSPLANT RECIPIENTS

This study is for people who have received a kidney transplant. After a transplant, patients need to take special medicines called immunosuppressants to stop their body from rejecting the new kidney. These medicines include CellCept, Prograf, and Prednisolone. We are looking at how taking a calcium supplement called Calcigran Forte at the same time might change the levels of these vital medicines in the body. The main goal is to understand if the calcium supplement makes these important anti-rejection drugs less effective or changes how they’re absorbed. This will help doctors make sure patients get the right doses of their medicines to keep their new kidney healthy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

25 Sep 2024

Kidney transplantation

What is this study about?

This study is designed for individuals who have undergone a kidney transplant. After receiving a new kidney, it's crucial to take specific medications called 'immunosuppressants.' These drugs, such as CellCept, Prograf, and Prednisolone, help prevent your body's immune system from attacking and rejecting the donated kidney. Sometimes, transplant patients also need to take other supplements, like calcium, to keep their bones strong.

The main purpose of this study is to investigate how taking a common calcium supplement, Calcigran Forte, at the same time as these vital immunosuppressant drugs affects their levels in your body. We want to understand if the calcium supplement changes how well your body absorbs these anti-rejection medicines or if it alters the amount of medicine that reaches your bloodstream. This is important because having the right amount of immunosuppressants in your body is key to the success of your kidney transplant.

By carefully measuring the levels of these medicines with and without the calcium supplement, researchers hope to gather valuable information. This knowledge will help doctors ensure that kidney transplant patients receive the correct doses of their medications, helping to protect their new kidney and maintain their overall health. It's about making sure your medicines work as effectively as possible.

Key takeaways

Study examines how calcium supplement affects transplant medicines.
Focuses on CellCept, Prograf, Prednisolone, and Calcigran Forte.
Aims to ensure proper dosing for kidney transplant patients.
Involves adults (18+) who have had a kidney transplant.
Will collect blood and possibly stool samples to measure drug levels.
Your participation helps improve care for transplant patients.

Who may be eligible?

This study is looking for adults who are aged 18 or older. There is no upper age limit, so people of all adult ages can take part.

Both men and women are welcome to join this research study. Your gender does not affect whether you can participate.

To be considered for this study, you must have previously had a kidney transplant and be taking the specific medicines being investigated. The research team will check if you meet all the necessary health requirements.

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 a kidney transplant?
Are you currently taking transplant medicines like CellCept, Prograf, or Prednisolone?
Are you a man or a woman? (Both are welcome)
Are you generally willing to provide blood samples for testing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to take your regular kidney transplant medicines like CellCept, Prograf, and Prednisolone. The study will involve giving you a calcium supplement, Calcigran Forte, at certain times.

To understand how your body handles the medicines, you will have several blood samples taken. These samples will help us measure the levels of your anti-rejection drugs. You might also be asked to provide stool samples for additional tests. The study will involve a few visits to the clinic for these assessments.

The research team will closely monitor your health throughout. The total duration of your involvement in the study will be explained in detail by the study staff.

Potential risks and benefits

Taking part in this study could help doctors understand more about how your transplant medicines work with other supplements, which may benefit future kidney transplant patients. You might not directly benefit from taking part, but your contribution is valuable for medical knowledge. Like all medical studies, there might be some minor risks, such as discomfort from blood draws, or potential mild stomach upset from the calcium supplement. All procedures will be carefully explained, and your safety is the priority. Remember, 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
Norway

Common questions

What is the main reason for this study?

The study wants to see how a calcium supplement (Calcigran Forte) affects the levels of important anti-rejection medicines in people who have had a kidney transplant.

What medicines are being looked at?

We are focusing on CellCept, Prograf, Prednisolone, and Calcigran Forte.

Who can join the study?

Adults aged 18 years or older, both men and women, who have had a kidney transplant.

Will I have to stop taking my regular medicines?

No, you will continue your regular transplant medicines. The study is about how they interact with a calcium supplement.

What does a 'Phase IV' study mean?

It means the medicines are already approved and widely used. This study is looking at how they work in real-world settings, often in combination with other common treatments.