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Comparing tacrolimus and mycophenolate mofetil bioequivalence in kidney transplant recipients taking immunosuppressive medications

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on patients who have received a kidney transplant and are taking medications to prevent organ rejection. The study will compare two pairs of medications: generic and brand-name versions of tacrolimus (Tacrolimus Ascend and Prograf) and mycophenolate mofetil (Mycophenolate Mofetil Accord and CellCept). These medications are commonly used to suppress the immune system in transplant patients to prevent rejection of the transplanted organ.

The purpose of the study is to determine if the generic versions of these medications work in the same way as the brand-name versions in kidney transplant patients. During the study, participants will take both generic and brand-name versions of their regular medications at different times. The medications will be given as oral capsules or tablets twice daily.

The study will last for 2 months, during which time researchers will monitor how the medications are processed by the body. This involves measuring the amount of medication in the blood at various times after taking the doses. The study will also look at how the medications interact with bacteria in the digestive system and how they are converted in the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medication regimen
You will be taking your regular medications: Prograf (tacrolimus) and CellCept (mycophenolate mofetil) twice daily
These medications help prevent organ rejection after kidney transplantation
Step 2
Switch to test medications
You will receive Tacrolimus Ascend (1 mg capsules) to replace Prograf
You will receive Mycophenolate Mofetil Accord (250 mg capsules) to replace CellCept
The medication schedule remains the same - twice daily dosing
Step 3
Monitoring period
Your blood levels of both medications will be measured over a 12-hour period
The following measurements will be taken: drug concentration in blood at various time points
Samples of your stool will be collected for analysis
Step 4
Study duration
The study period begins in August 2025
The study continues until December 2025
Your participation helps determine if the new medications work the same way as your current medications

Who can join the trial?

7 criteria

You must be a person who has received a kidney transplant and has been on stable medications to prevent organ rejection for at least two weeks
You must be currently taking both of these medications: - Prograf (tacrolimus) twice per day - CellCept (mycophenolate mofetil) twice per day
You must be at least 18 years old
You must be able to take your medications independently without assistance
You must be willing and able to sign an informed consent form, which means you understand and agree to participate in the study
You can be either male or female
You must not be part of a vulnerable population (such as prisoners or persons unable to consent for themselves)

Who cannot join the trial?

13 criteria

Age below 18 or above 65 years
Pregnancy or breastfeeding women
History of previous organ transplants other than kidney
Unstable kidney function (significant changes in kidney function tests)
Active infections or serious illnesses
Use of medications that can interact with tacrolimus (an anti-rejection medication) or mycophenolate mofetil (MMF, an immunosuppressant drug)
Known allergies to tacrolimus or mycophenolate mofetil
Participation in other clinical trials within the past 30 days
Inability to follow study procedures or attend scheduled visits
Significant liver problems or abnormal liver function tests
Uncontrolled medical conditions such as high blood pressure or diabetes
History of substance abuse within the past year
Mental conditions that could affect the ability to provide informed consent

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Verified
Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Tacrolimus (Prograf) is an immunosuppressive medication that helps prevent organ rejection in kidney transplant patients. It works by decreasing the activity of the immune system to protect the transplanted kidney. This medication is taken orally and needs to be taken consistently at the same time each day. Mycophenolate mofetil (CellCept) is another immunosuppressive medication used to prevent organ rejection in kidney transplant recipients. It works by reducing the activity of the immune system in a different way than tacrolimus. This medication helps protect the transplanted kidney by preventing the body from attacking it as a foreign object. Both medications are essential parts of the anti-rejection treatment plan for kidney transplant patients and are often used together to provide comprehensive protection against organ rejection.

What is already known about the treatment

Prograf
An immunosuppressive medication administered orally in capsule form, containing tacrolimus as the active ingredient. This prescription drug is widely used in organ transplantation medicine, particularly in kidney transplant recipients, to prevent organ rejection by suppressing the immune system. Tacrolimus works by inhibiting T-lymphocyte activation at the molecular level, which reduces the risk of transplant rejection, and belongs to the calcineurin inhibitor class of immunosuppressants. The medication requires careful blood level monitoring and is typically taken twice daily to maintain steady therapeutic concentrations.
CellCept
An immunosuppressive medication containing mycophenolate mofetil (MMF), administered orally in capsule or tablet form. It is commonly prescribed alongside other anti-rejection medications in organ transplantation, particularly for kidney transplant patients, to prevent organ rejection by reducing the body's immune response. The drug works by selectively inhibiting the proliferation of T and B lymphocytes, thereby preventing them from attacking the transplanted organ, and belongs to the class of anti-metabolite immunosuppressants. Regular blood monitoring is required to maintain appropriate therapeutic levels and prevent potential side effects.

Investigated diseases

End-stage Renal Disease
A condition where the kidneys permanently lose their ability to filter waste from the blood, requiring kidney transplantation. The disease develops gradually as kidney function deteriorates over time. It affects the body's ability to maintain proper fluid balance, remove waste products, and regulate various essential substances in the blood.
Kidney Transplant Rejection
A condition where the recipient's immune system recognizes the transplanted kidney as foreign and attempts to attack it. The rejection process can occur immediately after transplantation or develop over time. The immune response can damage the new kidney's tissues and affect its function.
Chronic Kidney Failure
A progressive condition where kidney function gradually declines over months or years. The kidneys become less efficient at filtering waste products from the blood and maintaining fluid balance. This condition affects various body systems and can lead to the need for kidney transplantation.