NCT01068067

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

July 28, 2010

Status Verified

January 1, 2010

Enrollment Period

2.8 years

First QC Date

February 11, 2010

Last Update Submit

July 26, 2010

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • acute rejection rate within two weeks after transplantation

    within two weeks after transplantation

  • serum creatinine at fourteen days after transplantation

    fourteen days after transplantation

Study Arms (2)

pharmacogenetics plus SchE guided dosing

EXPERIMENTAL
Other: drug (tacrolimus and SchE) and genetics

standard dosing

ACTIVE COMPARATOR
Drug: tacrolimus

Interventions

drug (tacrolimus and SchE) and geneticsOTHER

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.

pharmacogenetics plus SchE guided dosing
tacrolimusDRUG

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

standard dosing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (both males and females, 18-65 years) recipients underwent single primary renal transplantation in the First Affiliated Hospital of Sun Yat-sen University
  • Wish to participate in the study
  • Informed consent for the trial

You may not qualify if:

  • Patients with abnormal hepatic function, serious infection, malignant tumour, and diabetes mellitus
  • Patients with ABO-incompatible renal transplantation
  • Panel reactive antibody (PRA) levels greater than 30% before transplantation
  • Underwent combined organ transplantations
  • Except for SchE, other medication known to affect tacrolimus blood levels, such as diltiazem, verapamil, ketoconazole, itraconazole, erythromycin or clarithromycin was used
  • Allergic history to study medicines
  • During pregnancy or plan to get pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Related Links

MeSH Terms

Interventions

Pharmaceutical PreparationsTacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Min Huang, PhD

    Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

    STUDY CHAIR

  • Chang-Xi Wang, MD

    Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Huang, PhD

CONTACT

86-20-39943011huangmin@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Last Updated

July 28, 2010

Record last verified: 2010-01

Locations

CN(2)