MedTrace Logo

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

NCT01068067 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-07-28

No results posted yet for this study

Summary

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

Conditions

  • Renal Transplantation

Interventions

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).

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Min Huang, PhD · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

  • Chang-Xi Wang, MD · Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University

  • Jia-Li Li, PhD · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

  • Xue-Ding Wang, MD · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

  • Si-Yang Chen, MM · Anesthesia Department, the First Affiliated Hospital of Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068067 on ClinicalTrials.gov