Heart DiseasesPhase 3NCT00157014
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
A Phase 3 study testing Tacrolimus, Cyclosporine and Mycophenolate mofetil in people with Heart Diseases and Heart Transplantation, run by Astellas Pharma Inc at 13 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases, Heart Transplantation
- What is being tested?
- Tacrolimus, Cyclosporine and Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 10 May 2004to 18 Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (or their legal guardians) who are capable of understanding, and who have been fully informed of the purpose of the study and the risks of participation.
- Patients (or their legal guardians) who have signed and dated the Informed Consent form and are willing and able to follow the study protocol.
- Patients who are primary cadaveric heart transplant recipients.
- Males or females from birth.
- Female patients of child-bearing potential who have a current negative pregnancy test and agree to practice effective birth control, as judged by the investigator, while participating in the study. Prepubescent pediatric patients will not require pregnancy testing.
- Patients able to tolerate oral medication and who do not have a gastrointestinal condition likely to affect the absorption kinetics or metabolism of the oral study medications.
Who cannot join
- Previous organ transplant recipients.
- Multi-organ transplant recipients.
- Recipients of a heart from a donor with incompatible ABO blood type.
- Patients with significant graft dysfunction and/or significant de novo infection(s) at time of randomization
- Patients with known hypersensitivity to tacrolimus, cyclosporine, mycophenolate mofetil (MMF), daclizumab, prednisone, cremophor, polysorbate 80 and/or polyoxyl 60 hydrogenated castor oil (HCO-60).
- Patients who are pregnant or lactating or planning to become pregnant prior to completion of the study.
Show all 20Show fewer
- Patients who have consumed an investigational product in the 30 days prior to transplantation or at any time during post-transplantation follow-up.
- Patients receiving cholestyramine or colestipol.
- Patients having any one of the following at enrolment:
- History of malignancy, not chart-documented as cured or active malignancy (with exception of eradicable non-metastatic in-situ basal cell or squamous cell carcinoma).
- Leukopenia (white cell count < 2500/cu mm).
- Anemia (hemoglobin < 80 g/L).
- Positive test for hepatitis B surface antigen and/or hepatitis C.
- Historical positive test for human immunodeficiency virus (HIV).
- Serum creatinine > 230 umol/l.
- Continual elevation of AST and/or ALT to >= 3X the upper limit of normal.
- Body mass index (weight in kg/height in m2) > 30.
- Undiagnosed diabetes mellitus as determined by 2 hour (2h) oral glucose tolerance test (OGTT) or fasting glucose test or uncontrolled diabetes mellitus at screening. In either case, the patient may be declared as no longer excluded by this criterion upon establishment of control of the diabetes through appropriate medical management.
- Blood glucose >= 11.1 mmol/L at pre-operative assessment.
- Patients having a significant disease, substance dependency, or disability that may prevent adherence to, or understanding of, the protocol and/or the investigator's instructions.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Canada12 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Edmonton, Alberta, T6G 2B7
Study site
Edmonton, Alberta, T6G 2E1
Study site
Halifax, Nova Scotia, B3H 3A7
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H1T 1C8
Study site
Montreal, Quebec, H3A 1A1
Study site
Ottawa, Ontario, K1Y 4W7
Study site
Sainte-Foy, Quebec, G1V 4G5
Study site
Toronto, Ontario, M5G 1X8
Study site
Toronto, Ontario, M5G 2N2
Study site
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de Novo Cardiac Transplant: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens With MPA TDM
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
Read the detailed description
Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporine as their primary immunosuppressant
Two parallel active arms.
- Conditions
- Heart Diseases, Heart Transplantation
- Being tested
- Tacrolimus, Cyclosporine, Mycophenolate mofetil, Methylprednisolone, Prednisone
- Keywords
- Antirejection, Treatment Outcome, Immunosuppression, Treatment Effectiveness, Anti-rejection therapy
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf, FK506
Oral
CyclosporineDrug
Oral
Also called CellCept
Intravenous and Oral
Intravenous
PrednisoneDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus - Adult | Experimental | Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant Receives: Drug: Tacrolimus; Drug: Mycophenolate mofetil; Drug: Methylprednisolone; Drug: Prednisone |
| Cyclosporine - Adult | Active comparator | Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant Receives: Drug: Cyclosporine; Drug: Mycophenolate mofetil; Drug: Methylprednisolone; Drug: Prednisone |
| Tacrolimus - Pediatric | Experimental | Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant Receives: Drug: Tacrolimus; Drug: Mycophenolate mofetil; Drug: Methylprednisolone; Drug: Prednisone |
| Cyclosporine - Pediatric | Active comparator | Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant Receives: Drug: Cyclosporine; Drug: Mycophenolate mofetil; Drug: Methylprednisolone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies
The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).
The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).
Change is defined as Week 52 assessment- Week 2 assessment.
Measured: 2 Weeks and 52 Weeks
The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)
The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.
The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).
Change is defined as Week 52 assessment- Week 2 assessment.
Measured: 2 Weeks and 52 Weeks
Secondary outcomes (34)
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1
Change is defined as Week 52 assessment - Pre-Transplant assessment.
MCP-1= monocyte chemoattractant protein-1
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM
Change is defined as Week 52 assessment - Pre-Transplant assessment.
s-ICAM= soluble-intracellular adhesion molecule
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP
Change is defined as Week 52 assessment - Pre-Transplant assessment.
hsCRP= high-sensitivity C Reactive Protein
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars
Change is defined as Week 52 assessment - Pre-Transplant assessment.
T-bars = thiobarbituric acid reactive substances
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG
Change is defined as Week 52 assessment - Pre-Transplant assessment.
GSH/GSSG= ratio of reduced to oxidised glutathione
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP
Change is defined as Week 52 assessment - Pre-Transplant assessment.
BNP= Brain Natriuretic Peptide
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6
Change is defined as Week 52 assessment - Pre-Transplant assessment.
IL= Interleukin
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C
Change is defined as Week 52 assessment - Pre-Transplant assessment.
Measured: Pre-Transplant and 52 Weeks
Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria
Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Patients may report more than one acute rejection.
Measured: 52 Weeks
Time to First Acute Rejection Episode Following de Novo Cardiac Transplant
Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Time to first acute rejection is defined as: date of onset - date of transplant.
Measured: 52 Weeks
Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection
Severe Acute Rejection is defined as rejection with ISHLT Grade 4.
Measured: 52 Weeks
Number of Cardiac Rejection Episodes Requiring Treatment
The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise.
Measured: 52 Weeks
Mean Cases of Acute Rejection (MCAR) Per Patient
MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.
Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Measured: 52 Weeks
Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52
A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.
Measured: 26 Weeks and 52 Weeks
Number of Patients With Treatment Failure and Crossover for Treatment Failure
Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.
Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant.
Measured: 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment
Measured: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)
Change is defined as Week 52 assessment - Pre-Transplant assessment
Measured: Pre-Transplant and 52 Weeks
Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)
Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Patients may report more than one rejection episode.
Measured: 52 Weeks
Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)
Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Time to first acute rejection is defined as: date of onset - date of transplant.
Measured: 52 Weeks
Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)
Severe Acute Rejection was defined as rejection with ISHLT Grade 4.
Measured: 52 Weeks
Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)
A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise.
Measured: 52 Weeks
Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)
MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.
Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.
ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.
Measured: 52 Weeks
Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)
A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.
Measured: 26 Weeks and 52 Weeks
Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)
Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.
Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start10 May 2004
- Primary completion18 Jul 2008
- Study completion18 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157014
- Sponsor's protocol ID
- FKC-009
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2005
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de Novo Cardiac Transplant: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens With MPA TDM
- ClinicalTrials.gov ID
- NCT00157014
- Acronym / sponsor ID
- FKC-009
- Conditions
- Heart Diseases, Heart Transplantation
- Keywords
- Antirejection, Treatment Outcome, Immunosuppression, Treatment Effectiveness, Anti-rejection therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- 10 May 2004 (actual)
- Primary completion
- 18 Jul 2008 (actual)
- Study completion
- 18 Jul 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 21 Feb 2011
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 assess the safety and efficacy of tacrolimus in de novo heart transplantation.
Detailed description
Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporine as their primary immunosuppressant
Two parallel active arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus - Adult | Experimental | Drug: Tacrolimus, Drug: Mycophenolate mofetil, Drug: Methylprednisolone, Drug: PrednisoneAdults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| Cyclosporine - Adult | Active comparator | Drug: Cyclosporine, Drug: Mycophenolate mofetil, Drug: Methylprednisolone, Drug: PrednisoneAdults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant |
| Tacrolimus - Pediatric | Experimental | Drug: Tacrolimus, Drug: Mycophenolate mofetil, Drug: Methylprednisolone, Drug: PrednisonePediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
| Cyclosporine - Pediatric | Active comparator | Drug: Cyclosporine, Drug: Mycophenolate mofetil, Drug: Methylprednisolone, Drug: PrednisonePediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients (or their legal guardians) who are capable of understanding, and who have been fully informed of the purpose of the study and the risks of participation.
- Patients (or their legal guardians) who have signed and dated the Informed Consent form and are willing and able to follow the study protocol.
- Patients who are primary cadaveric heart transplant recipients.
- Males or females from birth.
- Female patients of child-bearing potential who have a current negative pregnancy test and agree to practice effective birth control, as judged by the investigator, while participating in the study. Prepubescent pediatric patients will not require pregnancy testing.
Key exclusion criteria (20 listed)
- Previous organ transplant recipients.
- Multi-organ transplant recipients.
- Recipients of a heart from a donor with incompatible ABO blood type.
- Patients with significant graft dysfunction and/or significant de novo infection(s) at time of randomization
- Patients with known hypersensitivity to tacrolimus, cyclosporine, mycophenolate mofetil (MMF), daclizumab, prednisone, cremophor, polysorbate 80 and/or polyoxyl 60 hydrogenated castor oil (HCO-60).
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 |
|---|---|---|
| TacrolimusAlso: Prograf, FK506Oral | Drug | Tacrolimus - Adult, Tacrolimus - Pediatric |
| CyclosporineOral | Drug | Cyclosporine - Adult, Cyclosporine - Pediatric |
| Mycophenolate mofetilAlso: CellCeptIntravenous and Oral | Drug | Cyclosporine - Adult, Cyclosporine - Pediatric, Tacrolimus - Adult, Tacrolimus - Pediatric |
| MethylprednisoloneIntravenous | Drug | Cyclosporine - Adult, Cyclosporine - Pediatric, Tacrolimus - Adult, Tacrolimus - Pediatric |
| PrednisoneOral | Drug | Cyclosporine - Adult, Cyclosporine - Pediatric, Tacrolimus - Adult, Tacrolimus - Pediatric |
Primary outcome
The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies
Time frame: 2 Weeks and 52 Weeks
The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase). The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH). Change is defined as Week 52 assessment- Week 2 assessment.
The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)
Time frame: 2 Weeks and 52 Weeks
The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK. The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH). Change is defined as Week 52 assessment- Week 2 assessment.
34 secondary outcomes
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C
Time frame: Pre-Transplant and 52 Weeks
Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria
Time frame: 52 Weeks
Time to First Acute Rejection Episode Following de Novo Cardiac Transplant
Time frame: 52 Weeks
Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection
Time frame: 52 Weeks
Number of Cardiac Rejection Episodes Requiring Treatment
Time frame: 52 Weeks
Mean Cases of Acute Rejection (MCAR) Per Patient
Time frame: 52 Weeks
Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52
Time frame: 26 Weeks and 52 Weeks
Number of Patients With Treatment Failure and Crossover for Treatment Failure
Time frame: 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)
Time frame: Pre-Transplant and 52 Weeks
Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)
Time frame: Pre-Transplant and 52 Weeks
Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)
Time frame: 52 Weeks
Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)
Time frame: 52 Weeks
Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)
Time frame: 52 Weeks
Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)
Time frame: 52 Weeks
Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)
Time frame: 52 Weeks
Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)
Time frame: 26 Weeks and 52 Weeks
Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)
Time frame: 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to Prescribing InformationLink provided by the sponsor.
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Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Medical Monitor study director
Astellas Pharma Canada, Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus, Cyclosporine and Mycophenolate mofetil in people with Heart Diseases and Heart Transplantation, run by Astellas Pharma Inc at 13 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 6 inclusion and 20 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (time frame: 2 Weeks and 52 Weeks). The study lists 2 primary outcomes in all. 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 Jun 2017.