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DIAMOND: Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01011205
Collaborator
(none)
893
Enrollment
72
Locations
3
Arms
39.2
Actual Duration (Months)
12.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
893 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 30, 2009
Actual Primary Completion Date :
Jan 4, 2013
Actual Study Completion Date :
Jan 4, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dosing Regimen 1

Advagraf + MMF + Corticosteroids (Bolus)

Drug: Advagraf
Capsule
Other Names:
  • MR4
  • FK506E
  • tacrolimus modified release

    • Drug: Mycophenolate Mofetil
    Solution for infusion
    Other Names:
  • MMF

    • Drug: Corticosteroids
    IV bolus
    Other Names:
  • Methylprednisolone or equivalent

    		•
    Experimental: Dosing Regimen 2

    Advagraf + MMF + Basiliximab + Corticosteroids (Bolus)

    Drug: Advagraf
    Capsule
    Other Names:
  • MR4
  • FK506E
  • tacrolimus modified release

    • Drug: Mycophenolate Mofetil
    Solution for infusion
    Other Names:
  • MMF

    • Drug: Basiliximab
    IV infusion
    Other Names:
  • Simulect

    • Drug: Corticosteroids
    IV bolus
    Other Names:
  • Methylprednisolone or equivalent

    		•
    Experimental: Dosing Regimen 3

    Advagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus)

    Drug: Advagraf
    Capsule
    Other Names:
  • MR4
  • FK506E
  • tacrolimus modified release

    • Drug: Mycophenolate Mofetil
    Solution for infusion
    Other Names:
  • MMF

    • Drug: Basiliximab
    IV infusion
    Other Names:
  • Simulect

    • Drug: Corticosteroids
    IV bolus
    Other Names:
  • Methylprednisolone or equivalent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula [24 weeks]

    Secondary Outcome Measures

    1. 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]

    2. GFR at 24 Weeks after transplantation measured by Iothalamate clearance [24 weeks]

    3. GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula [24 weeks]

    4. Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula [24 weeks]

    5. Incidence of and time to first incidence of acute rejection [24 weeks]

    6. Incidence of and time to first incidence of corticosteroid-resistant acute rejection [24 weeks]

    7. Overall frequency of acute rejection episodes [24 weeks]

    8. Incidence of and time to first incidence of biopsy confirmed acute rejection [24 weeks]

    9. Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection [24 weeks]

    10. Overall frequency of biopsy confirmed acute rejection episodes [24 weeks]

    11. Severity of biopsy confirmed acute rejection episodes [24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 160 Buenos Aires Argentina
    2 001 Innsbruck Austria 6020
    3 146 Minsk Belarus 220116
    4 008 Brussels Belgium 1070
    5 006 Gent Belgium 9000
    6 009 Leuven Belgium 3000
    7 010 Liege Belgium 4000
    8 163 Sao Paulo Brazil
    9 153 Edmonton Canada T6G2XB
    10 150 Halifax Canada B3H2Y9
    11 151 London Canada N6A5A5
    12 152 Montreal Canada H2X3J4
    13 154 Vancouver Canada N5Z3X7
    14 169 Bogata Colombia
    15 147 Prague Czechia 14021
    16 026 Helsinki Finland 130
    17 041 Besancon France 25030
    18 157 Bordeaux France 33076
    19 043 Caen France 14033
    20 031 Creteil France 94000
    21 039 Lyon France 69317
    22 045 Marseille France 13385
    23 158 Montpelier France 34295
    24 037 Nice France 06202
    25 042 Paris France 75571
    26 044 Paris France 75651
    27 035 Paris France 92118
    28 038 Strasbourg France 67098
    29 033 Toulouse France 31054
    30 034 Villejuif France 94804
    31 056 Berlin Germany 13353
    32 058 Erlangen Germany 91054
    33 051 Frankfurt Germany 60559
    34 055 Gottingen Germany 37099
    35 057 Hannover Germany 30625
    36 142 Jena Germany 07747
    37 053 Kiel Germany 24105
    38 054 Leipzig Germany 4103
    39 Site: 156 Mainz Germany
    40 052 Munster Germany 48149
    41 060 Regensberg Germany 93042
    42 059 Tubingen Germany 72076
    43 061 Budapest Hungary 1082
    44 070 Dublin Ireland 4
    45 073 Bergamo Italy 24122
    46 075 Bologna Italy 40138
    47 076 Genova Italy 16132
    48 077 Naples Italy 80131
    49 079 Naples Italy 80131
    50 072 Padova Italy 35127
    51 074 Rome Italy 144
    52 071 Udine Italy 33100
    53 Site: 166 Mexico City Mexico
    54 086 Warsaw Poland 02-097
    55 087 Warsaw Poland 2006
    56 091 Bucharest Romania 22328
    57 096 Moscow Russian Federation 123182
    58 097 Moscow Russian Federation 129090
    59 148 Johannesburg South Africa
    60 114 A Coruna Spain 15006
    61 109 Barcelona Spain 08036
    62 106 Barcelona Spain 08907
    63 110 Barcelona Spain 8035
    64 115 Madrid Spain 28034
    65 108 Madrid Spain 28041
    66 117 Madrid Spain 28222
    67 116 Zaragoza Spain 50009
    68 126 Gothenberg Sweden 41345
    69 131 Zurich Switzerland 8091
    70 136 Birmingham United Kingdom Bi5 2TH
    71 171 Leeds United Kingdom LS9 7TF
    72 138 London United Kingdom SE5 9RS

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Global Development - EU

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01011205
    Other Study ID Numbers:
    • PMR-EC-1106
    • 2008-002231-32
    • 2010-021075-89
    First Posted:
    Nov 11, 2009
    Last Update Posted:
    Nov 22, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Astellas Pharma Inc
    Immunosuppression
    Liver
    Transplant
    Advagraf
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Methylprednisolone
    Tacrolimus
    Basiliximab

    Study Results

    No Results Posted as of Nov 22, 2017