Kidney TransplantationPhase 4NCT00297310
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
A Phase 4 study testing tacrolimus in people with Kidney Transplantation and Transplantation, run by Janssen-Cilag Pty Ltd.
Trial summary
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation. Patients in one group will be treated with tacrolimus according current clinical practice. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Kidney Transplantation, Transplantation
- What is being tested?
- tacrolimus
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Apr 2007
- Phase
- Phase 4
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has end-stage kidney disease and is a suitable candidate for primary renal transplantation or re-transplantation
- Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor, at least 10 years of age, with compatible ABO blood type
Who cannot join
- Patients receiving a graft from a non-heart-beating donor
- known to have significant liver disease, or is receiving a graft from a hepatitis C or B positive donor
- previously received or is receiving an organ transplant other than a kidney
- taking diltiazem, or any of the other disallowed medications during the 7 days prior to, and the 30 day trial period, or has been taking an investigational drug in the past 28 days
- patient or donor known to be HIV positive
About this study
Official title: Pre-transplant Pharmacokinetics as a Predictor of the Tacrolimus Dose Requirement Post Renal Transplantation
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation. Patients in one group will be treated with tacrolimus according current clinical practice. The other group will have a pre-transplant assessment of their tacrolimus blood level concentration that will be used to guide post-transplantation tacrolimus dosing. Tacrolimus is a medicine that slows down the body's immune system. For this reason, it works as an anti-rejection medicine.
Read the detailed description
This study is a multicentre, open-label, prospective, 2-arm, phase IV study of tacrolimus in renal transplant recipients. Patients will be randomized to receive current clinical practice or to have a pre-transplant pharmacokinetic assessment of tacrolimus metabolism that will be used to guide post-transplantation tacrolimus dosing, with the aim of increasing the proportion of patients that achieve a tacrolimus whole blood trough level of >10 ng/mL by Day 3 post-transplantation. Patients randomized to Group 1 will take a single dose of tacrolimus (0.1 mg/kg) prior to transplantation and a blood sample will be taken to determine tacrolimus whole blood concentration at 2 hours post-dose. The result of this blood sample will be used to guide tacrolimus dosing post-transplantation. Patients that return a low tacrolimus blood concentration will have a post-transplantation starting dose of up to 0.3 mg/kg/day, whereas patients that return a high tacrolimus blood concentration will have a post-transplantation starting dose of 0.1 mg/kg/day. Patients randomized to Group 2 will also receive a single pre-operative dose of tacrolimus, but will not have their tacrolimus whole blood concentration measured at 2 hours post-dose. These patients will be managed as per standard care.
The primary objective of the trial is to compare, between the two groups, the proportion of patients that achieve a tacrolimus whole blood trough concentration of ³10 ng/mL by Day 3 post-transplantation. The hypothesis is that performing a tacrolimus whole blood concentration assessment 2 hours after a pre-operative dose (to guide tacrolimus dosing post-transplantation), will lead to an increase in the numbers of patients that achieve therapeutic blood concentrations post-transplant. The tacrolimus whole blood concentration at Day 3 post-transplantation is a marker of the risk of rejection and toxicity.
A substudy is being conducted which seeks to examine and compare clinical variability in absorption profile by measurement of the phenotype (blood levels) in kidney transplant recipients and determine the nature and extent of relationship with MDR-1 genotype, thus allowing the most predictive and cost effective method of determining tacrolimus dosing.
Pre-transplant: One single tacrolimus dose 0.1 mg/kg/day orally. Post-transplant: 0.15 - 0.3 mg/kg/day as two divided tacrolimus doses orally, the actual dose to be guided by the pre-transplant tacrolimus blood concentration.
- Conditions
- Kidney Transplantation, Transplantation
- Being tested
- tacrolimus
- Keywords
- Tacrolimus, Kidney transplantation, Transplantation, Kidney failure, chronic, P-Glycoprotein
- Medical subject headings
- Renal Insufficiency, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients that achieve a tacrolimus whole blood trough concentration of >=10 ng/mL by Day 3 post-transplantation
Secondary outcomes (1)
Time to achieve first trough concentration of >=10 ng/mL. Comparative number of dose changes in each arm post-transplantation. Number of patients with whole blood trough concentration above the recommended therapeutic range (>15 ng/mL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startMay 2004
- Primary completionOct 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag Pty Ltd Clinical Trial, Study director, Janssen-Cilag Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297310
- Sponsor's protocol ID
- CR005020
- Status last verified
- Apr 2010
- First submitted
- 24 Feb 2006
- Last updated
- 20 Jun 2011
- Results posted
- No
Publications
Campbell S, Hawley C, Irish A, Hutchison B, Walker R, Butcher BE, Ferrari P. Pre-transplant pharmacokinetic profiling and tacrolimus requirements post-transplant. Nephrology (Carlton). 2010 Oct;15(7):714-9. doi: 10.1111/j.1440-1797.2010.01351.x.
PubMed 21040167
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-transplant Pharmacokinetics as a Predictor of the Tacrolimus Dose Requirement Post Renal Transplantation
- ClinicalTrials.gov ID
- NCT00297310
- Acronym / sponsor ID
- CR005020
- Conditions
- Kidney Transplantation, Transplantation
- Keywords
- Tacrolimus, Kidney transplantation, Transplantation, Kidney failure, chronic, P-Glycoprotein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Janssen-Cilag Pty LtdIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Feb 2006 (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 evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation. Patients in one group will be treated with tacrolimus according current clinical practice. The other group will have a pre-transplant assessment of their tacrolimus blood level concentration that will be used to guide post-transplantation tacrolimus dosing. Tacrolimus is a medicine that slows down the body's immune system. For this reason, it works as an anti-rejection medicine.
Detailed description
This study is a multicentre, open-label, prospective, 2-arm, phase IV study of tacrolimus in renal transplant recipients. Patients will be randomized to receive current clinical practice or to have a pre-transplant pharmacokinetic assessment of tacrolimus metabolism that will be used to guide post-transplantation tacrolimus dosing, with the aim of increasing the proportion of patients that achieve a tacrolimus whole blood trough level of >10 ng/mL by Day 3 post-transplantation. Patients randomized to Group 1 will take a single dose of tacrolimus (0.1 mg/kg) prior to transplantation and a blood sample will be taken to determine tacrolimus whole blood concentration at 2 hours post-dose. The result of this blood sample will be used to guide tacrolimus dosing post-transplantation. Patients that return a low tacrolimus blood concentration will have a post-transplantation starting dose of up to 0.3 mg/kg/day, whereas patients that return a high tacrolimus blood concentration will have a post-transplantation starting dose of 0.1 mg/kg/day. Patients randomized to Group 2 will also receive a single pre-operative dose of tacrolimus, but will not have their tacrolimus whole blood concentration measured at 2 hours post-dose. These patients will be managed as per standard care.
The primary objective of the trial is to compare, between the two groups, the proportion of patients that achieve a tacrolimus whole blood trough concentration of ³10 ng/mL by Day 3 post-transplantation. The hypothesis is that performing a tacrolimus whole blood concentration assessment 2 hours after a pre-operative dose (to guide tacrolimus dosing post-transplantation), will lead to an increase in the numbers of patients that achieve therapeutic blood concentrations post-transplant. The tacrolimus whole blood concentration at Day 3 post-transplantation is a marker of the risk of rejection and toxicity.
A substudy is being conducted which seeks to examine and compare clinical variability in absorption profile by measurement of the phenotype (blood levels) in kidney transplant recipients and determine the nature and extent of relationship with MDR-1 genotype, thus allowing the most predictive and cost effective method of determining tacrolimus dosing.
Pre-transplant: One single tacrolimus dose 0.1 mg/kg/day orally. Post-transplant: 0.15 - 0.3 mg/kg/day as two divided tacrolimus doses orally, the actual dose to be guided by the pre-transplant tacrolimus blood concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has end-stage kidney disease and is a suitable candidate for primary renal transplantation or re-transplantation
- Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor, at least 10 years of age, with compatible ABO blood type
Key exclusion criteria (5 listed)
- Patients receiving a graft from a non-heart-beating donor
- known to have significant liver disease, or is receiving a graft from a hepatitis C or B positive donor
- previously received or is receiving an organ transplant other than a kidney
- taking diltiazem, or any of the other disallowed medications during the 7 days prior to, and the 30 day trial period, or has been taking an investigational drug in the past 28 days
- patient or donor known to be HIV positive
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 | Drug | – |
Primary outcome
The proportion of patients that achieve a tacrolimus whole blood trough concentration of >=10 ng/mL by Day 3 post-transplantation
1 secondary outcome
Time to achieve first trough concentration of >=10 ng/mL. Comparative number of dose changes in each arm post-transplantation. Number of patients with whole blood trough concentration above the recommended therapeutic range (>15 ng/mL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
- Derived from this study: PubMed 21040167Campbell S, Hawley C, Irish A, Hutchison B, Walker R, Butcher BE, Ferrari P. Pre-transplant pharmacokinetic profiling and tacrolimus requirements post-transplant. Nephrology (Carlton). 2010 Oct;15(7):714-9. doi: 10.1111/j.1440-1797.2010.01351.x.
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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.
Janssen-Cilag Pty Ltd Clinical Trial study director
Janssen-Cilag Pty Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tacrolimus in people with Kidney Transplantation and Transplantation, run by Janssen-Cilag Pty Ltd.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients that achieve a tacrolimus whole blood trough concentration of >=10 ng/mL by Day 3 post-transplantation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297310, which also lists 1 linked publication.
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 20 Jun 2011.