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
Recruitment status was Recruiting
Sponsor:
Sun Yat-sen University
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
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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:
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Tacrolimus
U.S. FDA Resources
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:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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 May 21, 2013