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

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01068067
• Other study ID #: TAC+WUZHI
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2010
• Last updated: July 26, 2010
• Start date: March 2010

Study information

• Verified date: January 2010
• Source: Sun Yat-sen University
• Contact: Min Huang, PhD
• Phone: 86-20-39943011
• Email: huangmin[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Other:
• 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.

Drug:
• tacrolimus
After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	acute rejection rate within two weeks after transplantation		within two weeks after transplantation	No
Secondary	serum creatinine at fourteen days after transplantation		fourteen days after transplantation	No

External Links

•   Cytochrome P450
•   Help Me Understand Genetics
•   Kidney (Renal) transplantation
•   Tacrolimus