Indian journal of urology : IJU : journal of the Urological Society of India · 2025
Exposure to mycophenolic acid at standard prescribed doses in renal transplantation recipients and clinical outcomes in the early posttransplantation period.
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Singh Sheetal, Panwar Ritika, Naithani Priyanka, Kathik Nasika Venkata Kanaka Naga, Sharma Neeru, Gowda Niveditha, Kenwar Deepesh B, Kumar S P Shiva, Singh Sarbpreet, Pattanaik Smita, Sharma Ashish
Аннотация
INTRODUCTION: Renal transplantation relies on effective immunosuppression. Mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF), is a crucial component. We investigated the relationship between exposure to MPA and early posttransplant outcomes.
METHODS: One hundred and twenty adult live-related renal transplant recipients receiving standard triple immunosuppression (Tacrolimus [Tac] tailored to C0 target of 10-15 ng/ml, MMF 1.5-2 g/day and prednisolone) were enrolled. Blood samples were collected to assess MPA exposure, i.e., area under the concentration-time curve (AUC0-12h), 4-weeks after transplantation. Clinical events like rejections and opportunistic infections were monitored during the first 4 weeks posttransplantation.
RESULTS: About two-thirds of participants were males (77:23); the average age of the cohort was 35.86 ± 10.4 years. The mean MPA exposure was 63.7 ± 23.1 μg × h/mL. 66.6% of the participants had exposure outside the recommended therapeutic window (30-60 μg × h/mL); 55.8% were supra-therapeutic, whereas 10.8% subtherapeutic. Only 33.4% of patients had MPA concentrations within the therapeutic range. The MPA exposure was significantly high for participants who had infection (66.2 ± 26.6 μg × h/mL, n = 24) compared to those who did not (55.3 ± 20.1 μg × h/mL, n = 96, P = 0.02). Thirteen patients had rejection, and there was no difference in MPA exposure compared to those who did not (P = 0.8) at 4 weeks. However, it was observed that Tac C0 in patients with history of rejection was higher (13.6 ± 3.3 ng/ml) compared to those who did not (11.7 ± 3.1 ng/ml, P = 0.005) due to dose up titration at the time of rejection.
CONCLUSION: We found that standard doses of 1.5-2 g/day MMF lead to overexposure of MPA in the majority of Indian renal transplant recipients in the early posttransplant period, and the higher exposure is linked to infections, underscoring the need for personalized mycophenolate dosing.
METHODS: One hundred and twenty adult live-related renal transplant recipients receiving standard triple immunosuppression (Tacrolimus [Tac] tailored to C0 target of 10-15 ng/ml, MMF 1.5-2 g/day and prednisolone) were enrolled. Blood samples were collected to assess MPA exposure, i.e., area under the concentration-time curve (AUC0-12h), 4-weeks after transplantation. Clinical events like rejections and opportunistic infections were monitored during the first 4 weeks posttransplantation.
RESULTS: About two-thirds of participants were males (77:23); the average age of the cohort was 35.86 ± 10.4 years. The mean MPA exposure was 63.7 ± 23.1 μg × h/mL. 66.6% of the participants had exposure outside the recommended therapeutic window (30-60 μg × h/mL); 55.8% were supra-therapeutic, whereas 10.8% subtherapeutic. Only 33.4% of patients had MPA concentrations within the therapeutic range. The MPA exposure was significantly high for participants who had infection (66.2 ± 26.6 μg × h/mL, n = 24) compared to those who did not (55.3 ± 20.1 μg × h/mL, n = 96, P = 0.02). Thirteen patients had rejection, and there was no difference in MPA exposure compared to those who did not (P = 0.8) at 4 weeks. However, it was observed that Tac C0 in patients with history of rejection was higher (13.6 ± 3.3 ng/ml) compared to those who did not (11.7 ± 3.1 ng/ml, P = 0.005) due to dose up titration at the time of rejection.
CONCLUSION: We found that standard doses of 1.5-2 g/day MMF lead to overexposure of MPA in the majority of Indian renal transplant recipients in the early posttransplant period, and the higher exposure is linked to infections, underscoring the need for personalized mycophenolate dosing.