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

Not Applicable

• Conditions: Renal Transplantation
• Interventions: Other: drug (tacrolimus and SchE) and genetics; Drug: tacrolimus

• Registration Number: NCT01068067
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Study Start: 2010-03
• Last Update Submitted: 2010-07-26
• Last Update Posted: 2010-07-28
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adult (both males and females, 18-65 years) recipients underwent single primary renal transplantation in the First Affiliated Hospital of Sun Yat-sen University
2. Wish to participate in the study
3. Informed consent for the trial

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Exclusion Criteria

1. Patients with abnormal hepatic function, serious infection, malignant tumour, and diabetes mellitus
2. Patients with ABO-incompatible renal transplantation
3. Panel reactive antibody (PRA) levels greater than 30% before transplantation
4. Underwent combined organ transplantations
5. Except for SchE, other medication known to affect tacrolimus blood levels, such as diltiazem, verapamil, ketoconazole, itraconazole, erythromycin or clarithromycin was used
6. Allergic history to study medicines
7. During pregnancy or plan to get pregnant during the study period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pharmacogenetics plus SchE guided dosing	drug (tacrolimus and SchE) and genetics	-
standard dosing	tacrolimus	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
acute rejection rate within two weeks after transplantation	within two weeks after transplantation
serum creatinine at fourteen days after transplantation	fourteen days after transplantation

Trial Locations

Locations (2)

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China