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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01068067

Enrollment

Registered

2010-02-12

Start date

2010-03-31

Completion date

Unknown

Last updated

2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Brief summary

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

Interventions

OTHERdrug (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.

DRUGtacrolimus

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
acute rejection rate within two weeks after transplantation	within two weeks after transplantation
serum creatinine at fourteen days after transplantation	fourteen days after transplantation

Countries

China

Contacts

Primary ContactMin Huang, PhD

huangmin@mail.sysu.edu.cn86-20-39943011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026