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

July 26, 2010 updated by: Sun Yat-sen University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Jia-Li Li, PhD
        • Principal Investigator:
          • Xue-Ding Wang, MD
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Chang-Xi Wang, MD
          • Phone Number: 813 86-20-87755766
          • Email: wcx6363@163.com
        • Sub-Investigator:
          • Qian Fu, MD
        • Sub-Investigator:
          • Long-Shan Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pharmacogenetics plus SchE guided dosing
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.
Active Comparator: standard dosing
Drug: tacrolimus
After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: not less than three days after initial dose and not more than one month
not less than three days after initial dose and not more than one month

Secondary Outcome Measures

Outcome Measure
Time Frame
acute rejection rate within two weeks after transplantation
Time Frame: within two weeks after transplantation
within two weeks after transplantation
serum creatinine at fourteen days after transplantation
Time Frame: fourteen days after transplantation
fourteen days after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Min Huang, PhD, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
  • Study Director: Chang-Xi Wang, MD, Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University
  • Principal Investigator: Jia-Li Li, PhD, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
  • Principal Investigator: Xue-Ding Wang, MD, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
  • Principal Investigator: Si-Yang Chen, MM, Anesthesia Department, the First Affiliated Hospital of Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (Estimate)

February 12, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAC+WUZHI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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