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

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What is this study about?

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.

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

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

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

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 Study?

  • 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 Study?

  • 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

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

No sites found in this category

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
18.08.2025

Trial locations

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.

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.

Trial ID:
2025-521800-22-00
Protocol code:
GenIS-BID
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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  • Study of immunosuppression reduction in kidney transplant patients with septic shock or respiratory failure receiving drug combination therapy in intensive care

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