Renal TransplantationNCT01068067
Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients
A study testing drug (tacrolimus and SchE) and genetics and tacrolimus in people with Renal Transplantation, run by Sun Yat-sen University at 2 sites in China.
Trial summary
The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- drug (tacrolimus and SchE) and genetics and tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Min Huang, PhD, 86-20-39943011, huangmin@mail.sysu.edu.cn
Jia-Li Li, PhD
- Not yet recruiting
Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Chang-Xi Wang, MD, 86-20-87755766 ext. 813, wcx6363@163.com
Qian Fu, MD
About this study
Official title: 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.
- Conditions
- Renal Transplantation
- Being tested
- drug (tacrolimus and SchE) and genetics, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
tacrolimusDrug
After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| pharmacogenetics plus SchE guided dosing | Experimental | Not described Receives: Other: drug (tacrolimus and SchE) and genetics |
| standard dosing | Active comparator | Not described Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within two weeks after transplantation
serum creatinine at fourteen days after transplantation
Measured: fourteen days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Min Huang, PhD, Study chair, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen UniversityChang-Xi Wang, MD, Study director, Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen UniversityJia-Li Li, PhD, Principal investigator, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen UniversityXue-Ding Wang, MD, Principal investigator, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen UniversitySi-Yang Chen, MM, Principal investigator, Anesthesia Department, the First Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068067
- Sponsor's protocol ID
- TAC+WUZHI
- Status last verified
- Jan 2010
- First submitted
- 11 Feb 2010
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Chinese Renal Transplant Recipients: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01068067
- Acronym / sponsor ID
- TAC+WUZHI
- Conditions
- Renal Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmacogenetics plus SchE guided dosing | Experimental | Other: drug (tacrolimus and SchE) and genetics |
| standard dosing | Active comparator | Drug: tacrolimus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug (tacrolimus and SchE) and geneticsPatients 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. | Other | pharmacogenetics plus SchE guided dosing |
| tacrolimusAfter transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg). | Drug | standard dosing |
Primary outcome
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
2 secondary outcomes
acute rejection rate within two weeks after transplantation
Time frame: within two weeks after transplantation
serum creatinine at fourteen days after transplantation
Time frame: fourteen days after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
- Help Me Understand GeneticsLink provided by the sponsor.
- Cytochrome P450Link provided by the sponsor.
- TacrolimusLink provided by the sponsor.
- Kidney (Renal) transplantationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Huang, PhD study chair
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Chang-Xi Wang, MD study director
Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University
Jia-Li Li, PhD principal investigator
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug (tacrolimus and SchE) and genetics and tacrolimus in people with Renal Transplantation, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Huang, PhD (86-20-39943011, huangmin@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2010.