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Tegoprazan maintains stable trough levels of tacrolimus and mycophenolate, with no vital changes in gastrointestinal symptoms, vital signs, or allograft function in kidney transplant recipients over 12 weeks.
A randomized clinical trial by Seong-Wook Lee et al. has illustrated that tegoprazan, a potassium-competitive acid blocker (P-CAB), is safe for use in kidney transplant recipients and does not interfere with blood levels of the commonly used immunosuppressants tacrolimus and mycophenolate. The study, which sought to assess the potential drug-drug interactions, encompassed 62 kidney transplant recipients who were randomly assigned to get either 50 mg of tegoprazan or 20 mg of pantoprazole daily over a 12-week period.
The trial utilized an innovative smart clinical trial platform, which incorporated remote monitoring and safety management systems. This allowed real-time tracking of drug adherence, vital signs, and gastrointestinal symptoms via a custom mobile app. Throughout the study, patients maintained 100% medication adherence. Overall, 13,726 biometric data points and 5,031 patient-reported questionnaire responses were collected. Furthermore, 5,704 feedback messages and 56 video consultations were also collected.
At the end of the 12-week follow-up, the mean trough levels of tacrolimus (5.5 ± 1.6 ng/mL for tegoprazan vs. 5.8 ± 2.0 ng/mL for pantoprazole; p = 0.50) and mycophenolate (2.7 ± 1.4 µg/mL vs. 2.6 ± 1.4 µg/mL; p = 0.57) showed no vital differences between the two groups. There were also no notable intragroup changes in trough levels from baseline. Additionally, gastrointestinal symptoms, vital signs, and kidney allograft function remained stable and similar between the two groups.
These findings substantiate that tegoprazan does not adversely impact the pharmacokinetics of tacrolimus or mycophenolate and exhibited a similar safety profile to pantoprazole in this population. Furthermore, the study underscores the effectiveness and feasibility of using remote digital platforms for conducting randomized clinical trials in transplant care.
Pharmaceuticals (Basel)
Effect of Tegoprazan on Tacrolimus and Mycophenolate Levels in Kidney Transplant Recipients: A Randomized Controlled Study Using a Smart Trial Platform
Seong-Wook Lee et al.
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