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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
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The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmacogenetics plus SchE guided dosing | Experimental |
| |
| standard dosing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug (tacrolimus and SchE) and genetics | Other | Patients were genotyped for the polymorphisms that can influence tacrolimus pharmacokinetics before transplantation. After transplantation, initial tacrolimus dosage was based on an algorism guided by pharmacogenetics and SchE. |
| Measure | Description | Time Frame |
|---|---|---|
| C0 of tacrolimus after the initial dose, the percentage of out-of-range C0 after initial dose, the number of dose adjustments made to achieve therapeutic range (5-10 ng/ml) and the dose requirement to reach therapeutic range | not less than three days after initial dose and not more than one month |
| Measure | Description | Time Frame |
|---|---|---|
| acute rejection rate within two weeks after transplantation | within two weeks after transplantation | |
| serum creatinine at fourteen days after transplantation | fourteen days after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Huang, PhD | Contact | 86-20-39943011 | huangmin@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Huang, PhD | Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University | Study Chair |
| Chang-Xi Wang, MD | Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Label | URL |
|---|---|
| Help Me Understand Genetics | View source |
| Cytochrome P450 | View source |
| Tacrolimus |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| tacrolimus | Drug | After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg). |
|
| Jia-Li Li, PhD | Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University | Principal Investigator |
| Xue-Ding Wang, MD | Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University | Principal Investigator |
| Si-Yang Chen, MM | Anesthesia Department, the First Affiliated Hospital of Sun Yat-sen University | Principal Investigator |
| Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Kidney (Renal) transplantation | View source |