Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients
NCT ID: NCT01068067
Last Updated: 2010-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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pharmacogenetics plus SchE guided dosing
drug (tacrolimus and SchE) and genetics
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.
standard dosing
tacrolimus
After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).
Interventions
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drug (tacrolimus and SchE) and genetics
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.
tacrolimus
After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).
Eligibility Criteria
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Inclusion Criteria
2. Wish to participate in the study
3. Informed consent for the trial
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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School of Pharmaceutical Sciences, Sun Yat-sen University
Principal Investigators
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Min Huang, PhD
Role: STUDY_CHAIR
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Chang-Xi Wang, MD
Role: STUDY_DIRECTOR
Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University
Jia-Li Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Xue-Ding Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Si-Yang Chen, MM
Role: PRINCIPAL_INVESTIGATOR
Anesthesia Department, the First Affiliated Hospital of Sun Yat-sen University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Help Me Understand Genetics
Cytochrome P450
Kidney (Renal) transplantation
Other Identifiers
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TAC+WUZHI
Identifier Type: -
Identifier Source: org_study_id
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