Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Treatments:
Tacrolimus
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