Heart TransplantationPhase 2NCT01332201
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
A Phase 2 study testing Advagraf and Prograf in people with Heart Transplantation and Lung Transplantation, run by Astellas Pharma Inc at 8 sites in 6 countries.
Trial summary
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation
- What is being tested?
- Advagraf and Prograf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Jul 2011to Nov 2013
- Phase
- Phase 2
- 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
- must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
- negative pregnancy test prior to enrolment (females)
- agree to practice effective birth control during the study
- treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (<230 µmol/l (<2.6 ml/dl)) on Day 1
Who cannot join
- receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
- pulmonary vascular resistance ≥4 Wood units despite medication
- required an emergency ventricular assist device within one week prior to transplantation
- significant renal impairment
- significant liver disease
- malignancies or a history of malignancy within the last 5 years
Show all 10Show fewer
- significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
- requires systemic immunosuppressive medication for any other indication than transplantation
- diagnosis of cystic fibrosis
- pregnant or breast-feeding
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
About this study
Official title: A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.
- Being tested
- Advagraf, Prograf
- Keywords
- Advagraf, Heart, Lung, Pancreas, Transplant, Immunosuppression, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Also called FK506E, MR4, tacrolimus modified release
oral
PrografDrug
Also called tacrolimus, FK506
oral
| Study group | Role | What they receive |
|---|---|---|
| Advagraf | Experimental | Not described Receives: Drug: Advagraf |
| Prograf | Active comparator | Not described Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine steady state systemic exposure (AUC 0-24h)
Measured: Day 1, Day 3, Day 7 and Day 42
Secondary outcomes (6)
determine Cmax (maximum concentration)
Measured: Day 1, Day 3, Day 7 and Day 42
determine tmax (time to attain Cmax)
Measured: Day 1, Day 3, Day 7 and Day 42
determine C24 (concentration prior to next morning dose)
Measured: Day 1, Day 3, Day 7 and Day 42
describe rejection episodes
Measured: up to 58 weeks
describe subject survival
Measured: up to 58 weeks
describe graft survival
Measured: up to 58 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332201
- Sponsor's protocol ID
- PMR-EC-1501
- Other IDs
- 2010-019859-21
- Status last verified
- Jun 2015
- First submitted
- 7 Apr 2011
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up
- ClinicalTrials.gov ID
- NCT01332201
- Acronym / sponsor ID
- PMR-EC-1501
- Keywords
- Advagraf, Heart, Lung, Pancreas, Transplant, Immunosuppression, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Apr 2011 (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.
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advagraf | Experimental | Drug: Advagraf |
| Prograf | Active comparator | Drug: Prograf |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
- negative pregnancy test prior to enrolment (females)
- agree to practice effective birth control during the study
- treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (<230 µmol/l (<2.6 ml/dl)) on Day 1
Key exclusion criteria (10 listed)
- receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
- pulmonary vascular resistance ≥4 Wood units despite medication
- required an emergency ventricular assist device within one week prior to transplantation
- significant renal impairment
- significant liver disease
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 |
|---|---|---|
| AdvagrafAlso: FK506E, MR4, tacrolimus modified releaseoral | Drug | Advagraf |
| PrografAlso: tacrolimus, FK506oral | Drug | Prograf |
Primary outcome
determine steady state systemic exposure (AUC 0-24h)
Time frame: Day 1, Day 3, Day 7 and Day 42
6 secondary outcomes
determine Cmax (maximum concentration)
Time frame: Day 1, Day 3, Day 7 and Day 42
determine tmax (time to attain Cmax)
Time frame: Day 1, Day 3, Day 7 and Day 42
determine C24 (concentration prior to next morning dose)
Time frame: Day 1, Day 3, Day 7 and Day 42
describe rejection episodes
Time frame: up to 58 weeks
describe subject survival
Time frame: up to 58 weeks
describe graft survival
Time frame: up to 58 weeks
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 16 Jun 2015.
- Link to results on EudraCTLink 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.
Use Central Contact study chair
Astellas Pharma Europe Ltd.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Advagraf and Prograf in people with Heart Transplantation and Lung Transplantation, run by Astellas Pharma Inc at 8 sites in 6 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 4 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: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, United Kingdom, Austria, Belgium, France and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
determine steady state systemic exposure (AUC 0-24h) (time frame: Day 1, Day 3, Day 7 and Day 42). 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 16 Jun 2015.