What is the target trough level for a cadaveric (cadaver) kidney transplant recipient regarding immunosuppressive therapy?

From the Guidelines

For cadaveric renal transplant patients, the recommended target trough level for tacrolimus is 6-10 ng/ml during the first month, followed by 4-8 ng/ml thereafter, as recommended by the most recent and highest quality study 1. The target trough levels for calcineurin inhibitors in cadaveric renal transplant patients vary based on time post-transplant and specific medication.

• For tacrolimus, the recommended target trough levels are 6-10 ng/ml during the first month, followed by 4-8 ng/ml thereafter, as this range has been associated with a strong recommendation and a high level of consensus 1.
• It is also recommended to combine tacrolimus with other immunosuppressive drugs, such as MMF, AZA, or mTORi, to allow for a lower range of tacrolimus trough levels and to help preserve renal function 1.
• The administration of basiliximab induction with delayed introduction of tacrolimus is strongly recommended in patients at risk of developing post-transplant renal dysfunction 1.
• Regular monitoring of renal function, drug levels, and signs of rejection or toxicity is essential for optimal management.
• Individual patient factors, including immunological risk, concomitant immunosuppressants, and kidney function, may necessitate personalized adjustments to these targets.
• Higher levels early post-transplant provide stronger immunosuppression when rejection risk is highest, while lower levels later reduce toxicity risks.
• The use of tacrolimus trough levels as a guide for dosage adjustments is supported by the evidence, which suggests that this approach can help minimize the risk of rejection and toxicity 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Target Trough Level for Cadaveric Renal Transplant

• The target trough level for tacrolimus in cadaveric renal transplant patients is not well established, but studies suggest that a level of 8 ng/mL or higher may be beneficial in preventing biopsy-proven acute rejection (BPAR) 2.
• A study published in 2017 found that patients with average tacrolimus trough levels of 8 ng/mL or higher in the first month after transplantation had a lower risk of BPAR during the first 12 months after transplant 2.
• Another study published in 2019 compared the outcomes of low-level and standard-level tacrolimus at different time points after kidney transplantation and found that standard-level tacrolimus (7-12 ng/mL for 0-2 months, 6-10 ng/mL for 3-6 months, and 5-8 ng/mL for 7-12 months) was associated with a lower incidence of BPAR and better renal allograft function 3.
• Other studies have reported similar target trough levels for tacrolimus, ranging from 6-10 ng/mL 4, 5.
• However, it's worth noting that the optimal target trough level for tacrolimus may vary depending on the individual patient and the specific immunosuppressive regimen used, and that close monitoring of tacrolimus levels and frequent dose adjustments may be necessary to optimize allograft function 6.

Factors Affecting Tacrolimus Trough Levels

• Tacrolimus trough levels can be affected by various factors, including the use of other medications such as rifampin, which can induce the hepatic cytochrome P4503A4 system and increase tacrolimus metabolism 6.
• Other medications, such as diltiazem, fluconazole, and clarithromycin, may also interact with tacrolimus and affect its trough levels 6.
• The use of basiliximab as an induction therapy may also affect tacrolimus trough levels and reduce the risk of acute rejection 4, 5.