Precision Monitoring of Tacrolimus and Mycophenolate Mofetil in Adult Liver Transplant Recipients: Randomized Controlled Trial

Enrollment and consent

After joining the study, you will sign a consent form that explains the purpose of the trial and the procedures you will undergo.

Your personal and medical information will be recorded to create a baseline profile.

Baseline medical assessment

A series of tests will be performed to evaluate your liver function, kidney function, blood sugar level, and blood pressure.

These results will be used to compare later measurements and to help determine the appropriate medication dose.

Start of study medication

You will begin taking two oral medicines:

tacrolimus, an immunosuppressive drug that helps prevent your body from rejecting the transplanted liver.

mycophenolate mofetil, another immunosuppressive drug that works together with tacrolimus.

The exact dose (measured in milligrams) will be prescribed by the study team according to the trial protocol and will be taken once daily.

You will continue these medications for the duration of the study, which is up to 12 months.

First week monitoring

During the first seven days, you will have blood tests to measure the level of tacrolimus in your bloodstream (called a trough concentration).

Kidney function and blood sugar will also be checked to detect any early changes.

If the drug level is too high or too low, the dose may be adjusted.

Regular follow‑up visits

You will attend clinic visits at weeks 2 and 4, and then approximately every month until month 12.

At each visit, blood will be drawn for:

- measurement of tacrolimus concentration,

- assessment of kidney function (eGFR),

- checking for signs of diabetes or high blood pressure,

- screening for infections.

Based on these results, the study team may modify the dose of tacrolimus or mycophenolate mofetil to keep you within the target range.

Monitoring for specific complications

Throughout the year, you will be evaluated for:

- new onset diabetes (need for diabetes medication),

- new or worsening high blood pressure (need for antihypertensive medication),

- signs of infection (including viral tests),

- neurological side effects that might require stopping tacrolimus.

If any of these occur, appropriate medical actions will be taken and the medication regimen may be changed.

Final 12‑month assessment

At the end of the 12‑month period, a comprehensive evaluation will be performed.

This includes a full set of blood tests, measurement of kidney function, assessment of liver health, and documentation of any adverse events that occurred during the study.

The results will determine whether the transplanted liver has remained healthy without rejection or loss.

Study completion

After the final assessment, the study medication will be stopped according to the protocol.

You will receive information about any further follow‑up that may be recommended by your regular care team.

All data collected will be used for analysis, and no additional study procedures will be required.