Not recruiting

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

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Oslo Universitetssykehus HF
Oslo, Norway

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Tacrolimus
Tacrolimus is administered orally in the form of capsules or as an injection. It is currently well-established in medical practice and literature as an immunosuppressive medication used primarily to prevent organ rejection in kidney transplant recipients. The drug works by inhibiting calcineurin, a protein phosphatase, which in turn reduces the activity of T-cells, a type of white blood cell involved in immune responses. Tacrolimus is classified as a calcineurin inhibitor.
Mycophenolate Mofetil
Mycophenolate mofetil is taken orally in capsule or tablet form. It is widely recognized in the medical field for its role in preventing organ rejection, particularly in kidney transplant patients. The medication functions by inhibiting inosine monophosphate dehydrogenase, an enzyme crucial for the proliferation of T and B lymphocytes, thereby suppressing the immune response. It belongs to the class of immunosuppressive agents.

Investigated diseases

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.