Lung and Heart-lung TransplantationPhase 4BASALTNCT00975663
Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation
A Phase 4 study testing Tacrolimus and MMF in people with Lung and Heart-lung Transplantation, run by University Hospital, Limoges at 9 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung and Heart-lung Transplantation
- What is being tested?
- Tacrolimus and MMF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Sep 2009to Feb 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years or more
- CF and non-CF patients receiving single-lung or double-lung or heart-lung transplantation for the first time
- Patients on oral tacrolimus and MMF for at least 48 hours at the time of inclusion (administration via a naso-gastric tube possible if necessary)
- Patients without progressive chronic pathology jeopardizing short term patient and graft survival
- Patients accepting to comply with at least the evaluation visits planned in the investigation center over the first three years post-transplantation (D7, D14, M1, M3, M6, M12, M18, M24, M30, M36)
- Patients giving their free and informed written consent to participate in this study
- Patients with a health insurance policy or registered under a health insurance program
Who cannot join
- Patients aged less than 18 years or patients over 18 years under guardianship
- Patients who disagree with this research
- Patients with a contra-indication to receiving tacrolimus or MMF
- Patients on cyclosporine, sirolimus or everolimus
- Patients who have already benefited from a solid organ transplantation in the past (including lung or heart-lung transplantation)
- Patients infected by Burkholderia cenocepacia (Burkholderia cepacia genomovar III)
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- Patients receiving HIV protease inhibitors (major pharmacokinetic interaction with tacrolimus)
- Pregnant or breastfeeding women or those of child-bearing age who do not use an efficient contraceptive method
- Drug users or patients suffering from neuro-psychiatric disorders preventing them from both proper comprehension of the protocol and reliable consent
- Patients already participating in another interventional clinical trial
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
France8 sites
Pôle Médecine Aiguë et Communautaire, Clinique de Pneumologie,
Grenoble
Service de Pneumologie, HCL Lyon
Lyon
ApHm -Chirurgie thoracique
Marseille
Service de Pneumologie-CHU de Nantes
Nantes
Service de Chirurgie Cardiovasculaire - Hôpital Georges Pompidou
Paris
Service de Pneumologie - CH de Suresnes
Paris
Service de Pneumologie - Phtisiologie - Hôpital Bichat
Paris
Service de Pneumologie - CHU de Strasbourg
Strasbourg
About this study
Official title: Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis
The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.
Read the detailed description
This research will be based on a prospective randomized trial comparing optimized TDM of tacrolimus and MMF to the current strategy of tacrolimus and MMF dose adjustment in lung transplant recipients. The study will focus on the first three years post-transplantation, as treatment failures (including BOS) occur mainly during this post-transplantation period. As the aim of tacrolimus and MMF dose individualization is to avoid over- or underexposure, for the purpose of this study treatment failure will be a composite criterion gathering events which reflect both over- and underexposure to tacrolimus and MMF.
Optimized TDM of tacrolimus and MMF based on blood tacrolimus and plasma MPA AUC Bayesian estimation will be compared to current strategies: tacrolimus dose adjustment based on trough levels (C0) and administration of a standard dose of MMF, decreased by the pulmonologist in case of adverse drug reactions or increased in case of inefficacy. The efficacy of optimized strategy vs. current strategies will be mainly evaluated through the incidence of treatment failure.
- Conditions
- Lung and Heart-lung Transplantation
- Being tested
- Tacrolimus and MMF
- Keywords
- Lung transplantation, heart-lung transplantation, therapeutic drug monitoring, tacrolimus, mycophenolate, immunosuppressant, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus and MMFDrug
Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.
Tacrolimus and MMFDrug
Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Optimized TDM of tacrolimus and MMF dosing Receives: Drug: Tacrolimus and MMF |
| 2 | Active comparator | Current tacrolimus and MMF dosing strategies Receives: Drug: Tacrolimus and MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunosuppressive treatment failure
Measured: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Secondary outcomes (6)
Efficacy score
Measured: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Toxicity score
Measured: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Benefit/risk ratio
Measured: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Each event composing the composite criterion
Measured: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Overall cost of patients monitoring
Measured: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Pharmacogenetic and proteomic analysis
Measured: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung and Heart-lung TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Pierre MARQUET, MD, Study director, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975663
- Sponsor's protocol ID
- I07038
- Acronym
- BASALT
- Status last verified
- Apr 2011
- First submitted
- 10 Sep 2009
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00975663
- Acronym / sponsor ID
- BASALT / I07038
- Conditions
- Lung and Heart-lung Transplantation
- Keywords
- Lung transplantation, heart-lung transplantation, therapeutic drug monitoring, tacrolimus, mycophenolate, immunosuppressant, pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Sep 2009 (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 in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.
Detailed description
This research will be based on a prospective randomized trial comparing optimized TDM of tacrolimus and MMF to the current strategy of tacrolimus and MMF dose adjustment in lung transplant recipients. The study will focus on the first three years post-transplantation, as treatment failures (including BOS) occur mainly during this post-transplantation period. As the aim of tacrolimus and MMF dose individualization is to avoid over- or underexposure, for the purpose of this study treatment failure will be a composite criterion gathering events which reflect both over- and underexposure to tacrolimus and MMF.
Optimized TDM of tacrolimus and MMF based on blood tacrolimus and plasma MPA AUC Bayesian estimation will be compared to current strategies: tacrolimus dose adjustment based on trough levels (C0) and administration of a standard dose of MMF, decreased by the pulmonologist in case of adverse drug reactions or increased in case of inefficacy. The efficacy of optimized strategy vs. current strategies will be mainly evaluated through the incidence of treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tacrolimus and MMFOptimized TDM of tacrolimus and MMF dosing |
| 2 | Active comparator | Drug: Tacrolimus and MMFCurrent tacrolimus and MMF dosing strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients aged 18 years or more
- CF and non-CF patients receiving single-lung or double-lung or heart-lung transplantation for the first time
- Patients on oral tacrolimus and MMF for at least 48 hours at the time of inclusion (administration via a naso-gastric tube possible if necessary)
- Patients without progressive chronic pathology jeopardizing short term patient and graft survival
- Patients accepting to comply with at least the evaluation visits planned in the investigation center over the first three years post-transplantation (D7, D14, M1, M3, M6, M12, M18, M24, M30, M36)
Key exclusion criteria (10 listed)
- Patients aged less than 18 years or patients over 18 years under guardianship
- Patients who disagree with this research
- Patients with a contra-indication to receiving tacrolimus or MMF
- Patients on cyclosporine, sirolimus or everolimus
- Patients who have already benefited from a solid organ transplantation in the past (including lung or heart-lung transplantation)
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 and MMFTacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals. | Drug | 1 |
| Tacrolimus and MMFTacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals. | Drug | 2 |
Primary outcome
Immunosuppressive treatment failure
Time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
6 secondary outcomes
Efficacy score
Time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Toxicity score
Time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Benefit/risk ratio
Time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Each event composing the composite criterion
Time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Overall cost of patients monitoring
Time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Pharmacogenetic and proteomic analysis
Time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
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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.
Pierre MARQUET, MD study director
CHU Limoges
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus and MMF in people with Lung and Heart-lung Transplantation, run by University Hospital, Limoges at 9 sites in 2 countries.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Belgium. 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.
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 was stopped early. Results are not available in the source record.
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?
Immunosuppressive treatment failure (time frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation). 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 26 Apr 2011.