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

Sun Yat-sen University

Status: Unknown

Conditions: Renal Transplantation

Treatments: Other: drug (tacrolimus and SchE) and genetics; Drug: tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01068067

TAC+WUZHI

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

pharmacogenetics plus SchE guided dosing

Experimental group

Treatment:

Other: drug (tacrolimus and SchE) and genetics

standard dosing

Active Comparator group

Treatment:

Drug: tacrolimus