Nephrotic Syndrome Clinical Trial
Official title:
Guangzhou Women and Children's Medical Center
Tacrolimus is recommended to be the first line therapeutic medication within the several
immunosuppressive agents when treating refractory pediatric nephrotic syndrome, because of
its definite efficacy and low toxicity. But there are still some key problems which hinder
the using of tacrolimus in clinic, such as its narrow therapeutic widow, great individual
difference of pharmacokinetics. Routine therapeutic drug monitoring(TDM) is needed in
practice. But the disadvantage of TDM is hysteresis, which could lead to treatment failure
or toxicity. To find out the reasons of great pharmacokinetic difference between patients
and find out the individual proper dosage before administration are important for the
clinical using of tacrolimus.
It is hot in research of tacrolimus in organ transplant field, such as the association
between gene polymorphisms of cytochrome P-450 3A4, 3A5 and multiple drug resistant
gene(MDR1) and concentration of tacrolimus. However, there is few study about
pharmacogenomics and metabonomics of tacrolimus in patients of nephrotic syndrome.
The aim is to study the relationships between pharmacogenomics, metabonomics of tacrolimus
and its efficacy, toxicity and blood concentration in patients of nephrotic syndrome, to
find out the exact dosage before administration, to provide reference to individual drug
administration.
Investigators will collect data about efficacy and adverse drug reaction(ADR) such as time of efficacy when evaluated, how to evaluate ADR, data of demography, etc. ;
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