Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
DIAMOND
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)
3 other identifiers
interventional
893
22 countries
68
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2009
Typical duration for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2013
CompletedNovember 1, 2024
October 1, 2024
3.3 years
November 10, 2009
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula
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)
24 weeks
GFR at 24 Weeks after transplantation measured by Iothalamate clearance
24 weeks
GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula
24 weeks
Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula
24 weeks
Incidence of and time to first incidence of acute rejection
24 weeks
- +6 more secondary outcomes
Study Arms (3)
Dosing Regimen 1
EXPERIMENTALAdvagraf + MMF + Corticosteroids (Bolus)
Dosing Regimen 2
EXPERIMENTALAdvagraf + MMF + Basiliximab + Corticosteroids (Bolus)
Dosing Regimen 3
EXPERIMENTALAdvagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus)
Interventions
Capsule
Solution for infusion
IV bolus
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- \< 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
160
Buenos Aires, Argentina
001
Innsbruck, 6020, Austria
146
Minsk, 220116, Belarus
008
Brussels, 1070, Belgium
006
Ghent, 9000, Belgium
009
Leuven, 3000, Belgium
010
Liège, 4000, Belgium
163
São Paulo, Brazil
153
Edmonton, T6G2XB, Canada
150
Halifax, B3H2Y9, Canada
151
London, N6A5A5, Canada
152
Montreal, H2X3J4, Canada
154
Vancouver, N5Z3X7, Canada
169
Bogata, Colombia
147
Prague, 14021, Czechia
026
Helsinki, 130, Finland
041
Besançon, 25030, France
157
Bordeaux, 33076, France
043
Caen, 14033, France
031
Créteil, 94000, France
039
Lyon, 69317, France
045
Marseille, 13385, France
158
Montpelier, 34295, France
037
Nice, 06202, France
042
Paris, 75571, France
044
Paris, 75651, France
035
Paris, 92118, France
038
Strasbourg, 67098, France
033
Toulouse, 31054, France
034
Villejuif, 94804, France
056
Berlin, 13353, Germany
058
Erlangen, 91054, Germany
051
Frankfurt, 60559, Germany
055
Göttingen, 37099, Germany
057
Hanover, 30625, Germany
142
Jena, 07747, Germany
053
Kiel, 24105, Germany
054
Leipzig, 4103, Germany
Site: 156
Mainz, Germany
052
Münster, 48149, Germany
060
Regensberg, 93042, Germany
059
Tübingen, 72076, Germany
061
Budapest, 1082, Hungary
070
Dublin, 4, Ireland
073
Bergamo, 24122, Italy
075
Bologna, 40138, Italy
076
Genova, 16132, Italy
077
Naples, 80131, Italy
079
Naples, 80131, Italy
072
Padua, 35127, Italy
074
Rome, 144, Italy
071
Udine, 33100, Italy
Site: 166
Mexico City, Mexico
086
Warsaw, 02-097, Poland
087
Warsaw, 2006, Poland
091
Bucharest, 22328, Romania
096
Moscow, 123182, Russia
097
Moscow, 129090, Russia
148
Johannesburg, South Africa
114
A Coruña, 15006, Spain
109
Barcelona, 08036, Spain
106
Barcelona, 08907, Spain
110
Barcelona, 8035, Spain
115
Madrid, 28034, Spain
108
Madrid, 28041, Spain
117
Madrid, 28222, Spain
116
Zaragoza, 50009, Spain
126
Gothenberg, 41345, Sweden
131
Zurich, 8091, Switzerland
136
Birmingham, Bi5 2TH, United Kingdom
171
Leeds, LS9 7TF, United Kingdom
138
London, SE5 9RS, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Global Development - EU
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 11, 2009
Study Start
September 30, 2009
Primary Completion
January 4, 2013
Study Completion
January 4, 2013
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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/.