Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Chinese Renal Transplant Recipients: A Prospective Randomized Controlled Study

Conditions
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Renal Transplantation

Intervention / Treatment
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* Other: drug (tacrolimus and SchE) and genetics
* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (both males and females, 18-65 years) recipients underwent single primary renal transplantation in the First Affiliated Hospital of Sun Yat-sen University Wish to participate in the study Informed consent for the trial Exclusion Criteria: Patients with abnormal hepatic function, serious infection, malignant tumour, and diabetes mellitus Patients with ABO-incompatible renal transplantation Panel reactive antibody (PRA) levels greater than 30% before transplantation Underwent combined organ transplantations Except for SchE, other medication known to affect tacrolimus blood levels, such as diltiazem, verapamil, ketoconazole, itraconazole, erythromycin or clarithromycin was used Allergic history to study medicines During pregnancy or plan to get pregnant during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pharmacogenetics plus SchE guided dosing<br> | Other: drug (tacrolimus and SchE) and genetics<br>* 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.<br>|
| Active Comparator: standard dosing<br> | Drug: tacrolimus<br>* After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |