Clinical trial NCT01068067: Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients
Official title: Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Chinese Renal Transplant Recipients: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2010-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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

Primary outcomes:
measure: 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
timeFrame: not less than three days after initial dose and not more than one month
Secondary outcomes:
measure: acute rejection rate within two weeks after transplantation
timeFrame: within two weeks after transplantation
measure: serum creatinine at fourteen days after transplantation
timeFrame: fourteen days after transplantation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
name: Min Huang, PhD
role: STUDY_CHAIR
affiliation: Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University
name: Chang-Xi Wang, MD
role: STUDY_DIRECTOR
affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
name: Jia-Li Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
name: Xue-Ding Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesia Department, the First Affiliated Hospital of Sun Yat-sen University
name: Si-Yang Chen, MM
role: PRINCIPAL_INVESTIGATOR
References: