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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01068067
First received: February 11, 2010
Last updated: July 26, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention
Renal Transplantation
Other: drug (tacrolimus and SchE) and genetics
Drug: tacrolimus

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Chinese Renal Transplant Recipients: A Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • acute rejection rate within two weeks after transplantation [ Time Frame: within two weeks after transplantation ] [ Designated as safety issue: No ]
  • serum creatinine at fourteen days after transplantation [ Time Frame: fourteen days after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068067

Contacts
Contact: Min Huang, PhD 86-20-39943011 huangmin@mail.sysu.edu.cn

Locations
China, Guangdong
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Min Huang, PhD    86-20-39943011    huangmin@mail.sysu.edu.cn   
Principal Investigator: Jia-Li Li, PhD         
Principal Investigator: Xue-Ding Wang, MD         
Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Chang-Xi Wang, MD    86-20-87755766 ext 813    wcx6363@163.com   
Sub-Investigator: Qian Fu, MD         
Sub-Investigator: Long-Shan Liu, MD         
Sponsors and Collaborators
Sun Yat-sen University
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
  More Information

Additional Information:
No publications provided

Responsible Party: Min Huang, School of Pharmaceutical Sciences, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01068067     History of Changes
Other Study ID Numbers: TAC+WUZHI
Study First Received: February 11, 2010
Last Updated: July 26, 2010
Health Authority: China: National Natural Science Foundation

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014