Liver TransplantationPhase 3DIAMONDNCT01011205
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
A Phase 3 study testing Advagraf, Mycophenolate Mofetil and Basiliximab in people with Liver Transplantation, run by Astellas Pharma Inc at 72 sites in 23 countries.
Trial summary
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Advagraf, Mycophenolate Mofetil and Basiliximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 893 participants
- Where
- 72 sitesin 23 countries
- Study dates
- 30 Sep 2009to 4 Jan 2013
- Phase
- Phase 3
- 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
- Undergoing orthotopic liver or split liver allograft transplantation
- Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Who cannot join
- Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
- Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
- Receiving ABO incompatible graft or a graft from a non heart beating donor
- Ongoing dosing with systemic corticosteroids
- Subjects with systemic infection requiring treatment except viral hepatitis
- Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
Show all 19Show fewer
- < 3 nodes
- no node larger than 5 cm
- no metastases
- no vascular tumoral invasion
- Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- Subject or donor known to be HIV positive
- Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
- Pregnant woman or breast-feeding mother
- Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
- Unlikely to comply with the Visits scheduled in the protocol
- Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
- Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Trial locations and contacts
72 sites in 23 countries.
72 sites in 23 countries
France14 sites
041
Besançon, 25030
157
Bordeaux, 33076
043
Caen, 14033
031
Créteil, 94000
039
Lyon, 69317
045
Marseille, 13385
158
Montpelier, 34295
037
Nice, 06202
042
Paris, 75571
044
Paris, 75651
035
Paris, 92118
038
Strasbourg, 67098
033
Toulouse, 31054
034
Villejuif, 94804
Germany12 sites
056
Berlin, 13353
058
Erlangen, 91054
051
Frankfurt, 60559
055
Göttingen, 37099
057
Hanover, 30625
142
Jena, 07747
053
Kiel, 24105
054
Leipzig, 4103
Site: 156
Mainz
052
Münster, 48149
060
Regensberg, 93042
059
Tübingen, 72076
Italy8 sites
073
Bergamo, 24122
075
Bologna, 40138
076
Genova, 16132
077
Naples, 80131
079
Naples, 80131
072
Padova, 35127
074
Rome, 144
071
Udine, 33100
Spain8 sites
114
A Coruña, 15006
109
Barcelona, 08036
106
Barcelona, 08907
110
Barcelona, 8035
115
Madrid, 28034
108
Madrid, 28041
117
Madrid, 28222
116
Zaragoza, 50009
Canada5 sites
153
Edmonton, T6G2XB
150
Halifax, B3H2Y9
151
London, N6A5A5
152
Montreal, H2X3J4
154
Vancouver, N5Z3X7
Belgium4 sites
008
Brussels, 1070
006
Ghent, 9000
009
Leuven, 3000
010
Liège, 4000
United Kingdom3 sites
136
Birmingham, Bi5 2TH
171
Leeds, LS9 7TF
138
London, SE5 9RS
About this study
Official title: A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
- Conditions
- Liver Transplantation
- Being tested
- Advagraf, Mycophenolate Mofetil, Basiliximab, Corticosteroids
- Keywords
- Immunosuppression, Liver, Transplant, Advagraf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Also called MR4, FK506E, tacrolimus modified release
Capsule
Also called MMF
Solution for infusion
BasiliximabDrug
Also called Simulect
IV infusion
CorticosteroidsDrug
Also called Methylprednisolone or equivalent
IV bolus
| Study group | Role | What they receive |
|---|---|---|
| Dosing Regimen 1 | Experimental | Advagraf + MMF + Corticosteroids (Bolus) Receives: Drug: Advagraf; Drug: Mycophenolate Mofetil; Drug: Corticosteroids |
| Dosing Regimen 2 | Experimental | Advagraf + MMF + Basiliximab + Corticosteroids (Bolus) Receives: Drug: Advagraf; Drug: Mycophenolate Mofetil; Drug: Basiliximab; Drug: Corticosteroids |
| Dosing Regimen 3 | Experimental | Advagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus) Receives: Drug: Advagraf; Drug: Mycophenolate Mofetil; Drug: Basiliximab; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula
Measured: 24 weeks
Secondary outcomes (11)
Incidence of and time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Measured: 24 weeks
GFR at 24 Weeks after transplantation measured by Iothalamate clearance
Measured: 24 weeks
GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula
Measured: 24 weeks
Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula
Measured: 24 weeks
Incidence of and time to first incidence of acute rejection
Measured: 24 weeks
Incidence of and time to first incidence of corticosteroid-resistant acute rejection
Measured: 24 weeks
Overall frequency of acute rejection episodes
Measured: 24 weeks
Incidence of and time to first incidence of biopsy confirmed acute rejection
Measured: 24 weeks
Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection
Measured: 24 weeks
Overall frequency of biopsy confirmed acute rejection episodes
Measured: 24 weeks
Severity of biopsy confirmed acute rejection episodes
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study start30 Sep 2009
- Primary completion4 Jan 2013
- Study completion4 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 893 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 Global Development - EU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011205
- Sponsor's protocol ID
- PMR-EC-1106
- Other IDs
- 2008-002231-32, 2010-021075-89, 2008
- Acronym
- DIAMOND
- Status last verified
- Oct 2024
- First submitted
- 10 Nov 2009
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)
- ClinicalTrials.gov ID
- NCT01011205
- Acronym / sponsor ID
- DIAMOND / PMR-EC-1106
- Conditions
- Liver Transplantation
- Keywords
- Immunosuppression, Liver, Transplant, Advagraf
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2009 (actual)
- Primary completion
- 4 Jan 2013 (actual)
- Study completion
- 4 Jan 2013 (actual)
- First posted
- 11 Nov 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.
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dosing Regimen 1 | Experimental | Drug: Advagraf, Drug: Mycophenolate Mofetil, Drug: CorticosteroidsAdvagraf + MMF + Corticosteroids (Bolus) |
| Dosing Regimen 2 | Experimental | Drug: Advagraf, Drug: Mycophenolate Mofetil, Drug: Basiliximab, Drug: CorticosteroidsAdvagraf + MMF + Basiliximab + Corticosteroids (Bolus) |
| Dosing Regimen 3 | Experimental | Drug: Advagraf, Drug: Mycophenolate Mofetil, Drug: Basiliximab, Drug: CorticosteroidsAdvagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing orthotopic liver or split liver allograft transplantation
- Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Key exclusion criteria (19 listed)
- Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
- Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
- Receiving ABO incompatible graft or a graft from a non heart beating donor
- Ongoing dosing with systemic corticosteroids
- Subjects with systemic infection requiring treatment except viral hepatitis
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: MR4, FK506E, tacrolimus modified releaseCapsule | Drug | Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3 |
| Mycophenolate MofetilAlso: MMFSolution for infusion | Drug | Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3 |
| BasiliximabAlso: SimulectIV infusion | Drug | Dosing Regimen 2, Dosing Regimen 3 |
| CorticosteroidsAlso: Methylprednisolone or equivalentIV bolus | Drug | Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3 |
Primary outcome
Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula
Time frame: 24 weeks
11 secondary outcomes
Incidence of and time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Time frame: 24 weeks
GFR at 24 Weeks after transplantation measured by Iothalamate clearance
Time frame: 24 weeks
GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula
Time frame: 24 weeks
Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula
Time frame: 24 weeks
Incidence of and time to first incidence of acute rejection
Time frame: 24 weeks
Incidence of and time to first incidence of corticosteroid-resistant acute rejection
Time frame: 24 weeks
Overall frequency of acute rejection episodes
Time frame: 24 weeks
Incidence of and time to first incidence of biopsy confirmed acute rejection
Time frame: 24 weeks
Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection
Time frame: 24 weeks
Overall frequency of biopsy confirmed acute rejection episodes
Time frame: 24 weeks
Severity of biopsy confirmed acute rejection episodes
Time frame: 24 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 1 Nov 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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 Global Development - EU
72 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Advagraf, Mycophenolate Mofetil and Basiliximab in people with Liver Transplantation, run by Astellas Pharma Inc at 72 sites in 23 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 2 inclusion and 19 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in France, Germany, Italy, Spain, Canada and 18 more countries. 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?
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?
Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula (time frame: 24 weeks). 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 1 Nov 2024.