Transplantation Clinical Trial
The purpose of this study is to determine whether functional genetic variants can affect tacrolimus dose corrected trough levels and associate with the side effects in Chinese renal transplant recipients.
Tacrolimus is an effective immunosuppressive drug widely used in solid organ transplantation
to prevent rejection. It is characterized by a narrow therapeutic range and large inter- and
intra- individual variability in its pharmacokinetics. Many factors are associated with the
variability. Of these factors, genetic factor play an important role. Full understanding of
this mechanism is important for the personalized use of tacrolimus and reducing the risk of
side effects.The CYP3A5*3 (A6986G) resulting in a splicing defect and the absence of protein
activity, was identified as a functional variant (Kuehl P.2001). The CYP3A4*1G was also
reported as a functional variant (Richards-Waugh LL. 2014). In addition, other functional
variants will also be identified and analyzed in our project.
Our project has two parts:first, retrospective study, 839 renal transplant recipients using
tacrolimus as immunosuppressive drug were recruited from Nanfang Hospital. Fifty-eight SNPs
from GWAS, GTEx and promoter region of CYP3A gene were genotyped. The association of 58 SNPs
on the dose corrected tacrolimus trough levels and side effects (acute rejection,
nephrotoxicity and neurotoxicity) were analyzed. Luciferase reporter gene assay were used to
identify the functional variants. Second, in this part, there is another renal
transplantation cohort. For this cohort, it was a retrospective cohort. All the patients will
be stratified to different groups according to the different genotypes. The side effects
(acute rejection, nephrotoxicity and neurotoxicity) will be observed.During the study period,
all the therapeutic procedures of the patients are as usual.
This will be the largest cohort of this kind of study in Chinese population. The findings
will be useful for the patients to improve the therapeutic efficacy and reduce the side
effects.
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