Kidney Transplantation RecipientsNCT02356146
First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction
An observational study of Kidney Transplantation Recipients, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Kidney Transplantation Recipients
- What is being tested?
- Tacrolimus C12
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Jun 2015
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All KT recipient who transplanted and will be transplanted in King Chulalongkorn Memorial Hospital from 2012-2015
Who may be able to join
- All KT recipients
Who cannot join
- Recipient who not receiving tacrolimus
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok, 10330
Natavudh Townamchai, MD, +66894904222, ntownamchai@gmail.com
About this study
Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose administration prior to kidney transplantation.
Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were recorded.
The genotyping, TacC12, and target tacrolimus dosage have good correlations.
- Conditions
- Kidney Transplantation Recipients
- Being tested
- Tacrolimus C12
- Keywords
- Kidney transplantation, genotype, tacrolimus, CYP3A5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus C12Drug
| Study group | Role | What they receive |
|---|---|---|
| All KT recipient | Not described Receives: Drug: Tacrolimus C12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
target tacrolimus dose at 3 months
Measured: 3 months
Secondary outcomes (2)
rate of rejection
Measured: 3-12 months
rate of CNI toxicity
Measured: 2-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2012
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplantation RecipientsStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natavudh Townamchai, MD, Chulalongkorn University
- Investigators
- Natavudh Townamchai, MD, Principal investigator, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356146
- Sponsor's protocol ID
- IRB225/56
- Status last verified
- Feb 2015
- First submitted
- 1 Feb 2015
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction
- ClinicalTrials.gov ID
- NCT02356146
- Acronym / sponsor ID
- IRB225/56
- Conditions
- Kidney Transplantation Recipients
- Keywords
- Kidney transplantation, genotype, tacrolimus, CYP3A5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 5 Feb 2015 (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.
Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose administration prior to kidney transplantation.
Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were recorded.
The genotyping, TacC12, and target tacrolimus dosage have good correlations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All KT recipient | – | Drug: Tacrolimus C12 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All KT recipient who transplanted and will be transplanted in King Chulalongkorn Memorial Hospital from 2012-2015
Key inclusion criteria (1 listed)
- All KT recipients
Key exclusion criteria (1 listed)
- Recipient who not receiving tacrolimus
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 |
|---|---|---|
| Tacrolimus C12 | Drug | All KT recipient |
Primary outcome
target tacrolimus dose at 3 months
Time frame: 3 months
2 secondary outcomes
rate of rejection
Time frame: 3-12 months
rate of CNI toxicity
Time frame: 2-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
Related trials for Kidney Transplantation Recipients
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
Active, not recruitingPhase 1/2
Carfilzomib and Belatacept for Desensitization
Highly Sensitized Prospective Kidney Transplant Recipients
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.
Natavudh Townamchai, MD principal investigator
Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation Recipients, run by Chulalongkorn University at 1 site in Thailand.
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 1 inclusion and 1 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 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 Natavudh Townamchai, MD (+66894904222, ntownamchai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target tacrolimus dose at 3 months (time frame: 3 months). 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 5 Feb 2015.