Effect of antimicrobial drugs on tacrolimus and mycophenolate mofetil pharmacokinetics in kidney transplant recipients

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What is this study about?

The study focuses on people who have received a Kidney transplantation. After the transplant, patients normally take two medicines, mycophenolate mofetil and tacrolimus, to keep the new organ from being rejected. The investigation looks at how taking ordinary antimicrobial drugs – medicines used to treat infections – might change the way these transplant medicines work in the body. “Pharmacokinetics” means how quickly a drug is absorbed, moves through the body, and is cleared out.

The purpose of the study is to find out whether antimicrobial medicines affect the levels of the transplant drugs in the blood and alter the composition of the gut microbiome. Participants will continue their regular transplant medication schedule, and when an antimicrobial drug is prescribed as part of normal care, additional blood samples will be collected at several time points to measure drug concentrations. Small stool samples may also be taken to examine changes in intestinal bacteria. The overall study period lasts several weeks, with follow‑up visits to monitor any differences.

1 start study medication

after joining the study you will begin taking the two study drugs as prescribed.

2 take mycophenolate mofetil

take a total of 2000 mg of mycophenolate mofetil each day by mouth.

the dose is usually divided into four 500 mg film‑coated tablets taken with food, but follow the exact schedule given by the study team.

3 take tacrolimus

take a total of 30 mg of tacrolimus each day by mouth.

the medication is supplied as 1 mg hard capsules; the number of capsules to reach the prescribed dose will be indicated by the study team, and the dose is typically taken once daily.

4 provide blood samples for pharmacokinetic analysis

attend scheduled clinic visits where a blood sample will be drawn to measure the levels of the study drugs in your bloodstream.

samples are collected at several time points after a dose to determine exposure (a u c) and peak concentration (c max).

these measurements help assess how the drugs are processed in your body.

5 provide stool samples for microbiome assessment

at designated visits you will be asked to give a stool sample.

the sample is used to evaluate the composition of gut bacteria and how they may affect the study drugs.

6 continue medication and sample collection for the study period

you will keep taking the prescribed doses of mycophenolate mofetil and tacrolimus for the entire duration of the trial.

regular blood and stool collections will continue according to the study schedule.

7 final assessment and end of study medication

at the conclusion of the trial you will undergo a final assessment, which includes a last set of blood and stool samples.

after this visit the study medication will be stopped as directed.

Who Can Join the Study?

  • Be a kidney transplant recipient who has been on a steady immunosuppressive therapy (medicines that keep the body from rejecting the new kidney) for at least two weeks and needs an antimicrobial treatment (antibiotic or similar drug) that will last more than five days; examples include ciprofloxacin, meropenem, trimethoprim‑sulfamethoxazole, or other similar drugs.
  • Currently take an immunosuppressive drug regimen that includes either Prograf® (tacrolimus taken twice daily) or Advagraf® (tacrolimus taken once daily) and/or CellCept®/Mycophenolate mofetil Accord® (mycophenolate mofetil taken twice daily). Tacrolimus and mycophenolate mofetil are medicines that help prevent the body from attacking the transplanted kidney.
  • Be 18 years of age or older.
  • Be able to follow the medical treatment plan on your own, without needing constant help.
  • Sign a written informed consent form agreeing to take part in the study.

Who Cannot Join the Study?

  • Had a kidney transplant that was rejected within the past month and was treated with the steroid medication methylprednisolone (a strong anti‑inflammatory drug).
  • Had an infection that required antibiotics in the last 12 weeks (about three months).
  • Has been admitted to the intensive care unit (ICU) because of an infection.
  • Has changed any medicines that can affect the study drugs tacrolimus (Tac) or mycophenolate mofetil (MMF) between study visits, such as (but not limited to) diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, voriconazole, ritonavir, cholestyramine, or rifampicin. These are drugs that can interfere with how Tac or MMF work in the body.
  • Has severe diarrhea at the time of the study tests, or has had unusually loose or watery stools for the week before the tests.
  • Is a woman who is breastfeeding, currently pregnant, or could become pregnant and is not using a highly effective birth control method.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

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 yet recruiting
01.09.2026

Trial locations

CellCept is a tablet that contains mycophenolate mofetil, a medicine that helps stop the immune system from attacking a newly transplanted kidney. In this study, participants take the tablet by mouth to see how other drugs might change the way mycophenolate works in the body and how it affects the gut bacteria.

Mycophenolate mofetil Accord is another brand of the same medicine, mycophenolate mofetil, also taken as a tablet by mouth. It serves the same purpose as CellCept – to suppress the immune response after a kidney transplant – and is used in the trial to compare how different antimicrobial drugs may influence its behavior in the body and the gut microbiome.

Advagraf is a hard capsule that contains tacrolimus, a medication that also suppresses the immune system to protect a transplanted kidney from rejection. Participants swallow the capsule, and the study looks at how antimicrobial drugs might affect the amount of tacrolimus that reaches the bloodstream and its impact on gut bacteria.

PROGRAF is another brand of tacrolimus, provided as a capsule taken by mouth. Like Advagraf, it works to prevent the immune system from attacking the new kidney, and the trial uses it to examine whether other drugs change its absorption and its interaction with the gut microbiome.

Investigated Diseases:

Kidney transplantation – Kidney transplantation is the surgical placement of a healthy donor kidney into a person whose own kidneys no longer work adequately. After surgery, the transplanted organ begins to filter blood, producing urine and helping to regulate fluid and electrolytes. Over time, the new kidney can maintain normal kidney function, but the recipient’s immune system may gradually recognize it as foreign, leading to a slow decline in function if not controlled. The transplanted kidney can also be affected by injuries, infections, or chronic changes that reduce its filtering ability. Monitoring of kidney performance shows how the organ adapts and ages within the recipient’s body.

Trial ID:
2026-527106-20-00
Protocol code:
AXIS
Trial Phase:
Therapeutic confirmatory (Phase III)

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