Study on the Effects of Calcium, Tacrolimus, and Mycophenolate Mofetil in Patients with Kidney Transplants

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What is this study about?

This clinical trial is focused on studying the effects of certain medications in individuals who have undergone a kidney transplantation. The medications being studied include CellCept (which contains the active ingredient mycophenolate mofetil), Prograf (which contains tacrolimus), and Prednisolone. Additionally, the trial will examine the impact of a calcium supplement called Calcigran Forte, which contains colecalciferol (a form of vitamin D) and calcium.

The purpose of the study is to investigate how the calcium supplement affects the way the body processes the medications tacrolimus and mycophenolate mofetil in people who have had a kidney transplant. Participants in the study will continue their regular medication regimen, which includes taking Prograf, CellCept, and Prednisolone, while also taking the calcium supplement. The study will monitor how these medications are absorbed and processed in the body over a period of time.

Throughout the study, participants will be asked to take their medications as prescribed and may be required to provide samples for analysis. The study aims to provide valuable information on the interaction between the calcium supplement and the immunosuppressive drugs used by kidney transplant recipients. This information could help improve treatment plans and outcomes for individuals who have received a kidney transplant.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be kidney transplant recipients on stable immunosuppressive therapy for at least the last 5 days. The therapy includes Prograf (tacrolimus), CellCept (mycophenolate mofetil), and prednisolone.

Participants must be over 18 years old, require calcium/vitamin D supplements, and be able to manage their treatment independently. Informed consent is required.

2 medication regimen

Participants will continue their current immunosuppressive regimen, which includes Prograf (tacrolimus) taken twice daily, CellCept (mycophenolate mofetil) taken twice daily, and prednisolone.

In addition, participants will receive Calcigran Forte (calcium and vitamin D supplement) to assess its effect on the pharmacokinetics of tacrolimus and mycophenolate mofetil.

3 administration routes

CellCept is administered orally or intravenously as a film-coated tablet.

Prograf is administered orally or intravenously as a hard capsule.

Calcigran Forte is administered orally as a chewable tablet.

Prednisolone is administered orally as a tablet.

4 study duration

The study is expected to continue until March 31, 2025. Participants will be monitored throughout this period to assess the primary and secondary endpoints.

5 primary and secondary endpoints

The primary endpoint involves measuring the concentration and absorption of tacrolimus and mycophenolate mofetil with and without the calcium supplement.

Secondary endpoints include detailed pharmacokinetic parameters of tacrolimus, mycophenolate mofetil, and prednisolone, as well as analyses of fecal samples.

Who Can Join the Study?

  • Must have had a kidney transplant and be on stable medication to prevent organ rejection for the last 5 days.
  • Must be taking a specific combination of medications: Prograf® (tacrolimus twice daily), CellCept® (mycophenolate mofetil twice daily), and prednisolone.
  • Must be over 18 years old.
  • Must need a calcium/vitamin D supplement because their daily calcium intake is less than 1000 mg.
  • Must be able to follow the medical treatment plan on their own.
  • Must have signed a document agreeing to participate in the study, known as informed consent.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not recruiting
02.09.2024

Trial locations

Calcigran Forte is a calcium supplement used in this trial to study its effect on the absorption and processing of other medications in the body. It is given to kidney transplant recipients to see how it interacts with their regular medications.

Tacrolimus is an immunosuppressive medication used to prevent the body from rejecting a transplanted kidney. In this trial, researchers are examining how taking it with a calcium supplement affects its levels in the body.

Mycophenolate Mofetil is another immunosuppressive drug used to help prevent organ rejection in kidney transplant patients. The trial is investigating how its absorption and effectiveness might change when taken with a calcium supplement.

Kidney Transplantation – Kidney transplantation is a medical procedure where a healthy kidney from a donor is placed into a person whose kidneys are no longer functioning properly. This condition arises when the kidneys lose their ability to filter waste and excess fluids from the blood, leading to a buildup of harmful substances in the body. Over time, the transplanted kidney takes over the work of the failed kidneys, helping to restore normal kidney function. The progression involves the body accepting the new kidney and the gradual improvement of kidney function. However, the body may sometimes recognize the new kidney as foreign and attempt to reject it, which is a critical aspect of the post-transplant period. Regular monitoring and medication are essential to ensure the transplanted kidney functions well over time.

Trial ID:
2024-515164-30-00
Protocol code:
CalciTx
Trial Phase:
Therapeutic confirmatory (Phase III)

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