Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| good efficacy | using therapeutic drug monitoring to adjust the dose of tacrolimus. patients can reach effective outcome. |
| |
| poor efficacy | using therapeutic drug monitoring to adjust the dose of tacrolimus. patients can not reach effective outcome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic drug monitoring | Other | with therapeutic drug monitoring , dose of tacrolimus can be adjusted by therapeutic drug monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| "Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism" | genotype are collected from hospital system. | 1 week |
| "Concentration as measured by liquid chromatography mass spectrometry" | concentration of tacrolimus are collected from hospital system. | 1 week |
| "Relationship between genotypes and concentration as analyzed at 1 week" | using Statistic Package for Social Science 21.0 software to analyze the relationship between gene polymorphism and concentration. | 1 week |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
pediatric patients with nephrotic syndrome
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Min Huang, Doctor | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou women and children's medical center | Guangzhou | Guangdong | 510623 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31902946 | Derived | Mo X, Li J, Liu Y, Liao X, Tan M, Chen Y, He F, He Y, Li Y, Huang M. Kidney podocyte-associated gene polymorphisms affect tacrolimus concentration in pediatric patients with refractory nephrotic syndrome. Pharmacogenomics J. 2020 Aug;20(4):543-552. doi: 10.1038/s41397-019-0141-x. Epub 2020 Jan 6. |
Not provided
Not provided
we are carrying out experiment now. Data is not ready to publish for not completing the study. We will share data when we complete our study.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
DNAs extracted from whole blood are stored in freezer with -80 centigrade.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |