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

November 20, 2017 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

893

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • 160
  • Austria
      • Innsbruck, Austria, 6020
        • 001
  • Belarus
      • Minsk, Belarus, 220116
        • 146
  • Belgium
      • Brussels, Belgium, 1070
        • 008
      • Gent, Belgium, 9000
        • 006
      • Leuven, Belgium, 3000
        • 009
      • Liege, Belgium, 4000
        • 010
  • Brazil
      • Sao Paulo, Brazil
        • 163
  • Canada
      • Edmonton, Canada, T6G2XB
        • 153
      • Halifax, Canada, B3H2Y9
        • 150
      • London, Canada, N6A5A5
        • 151
      • Montreal, Canada, H2X3J4
        • 152
      • Vancouver, Canada, N5Z3X7
        • 154
  • Colombia
      • Bogata, Colombia
        • 169
  • Czechia
      • Prague, Czechia, 14021
        • 147
  • Finland
      • Helsinki, Finland, 130
        • 026
  • France
      • Besancon, France, 25030
        • 041
      • Bordeaux, France, 33076
        • 157
      • Caen, France, 14033
        • 043
      • Creteil, France, 94000
        • 031
      • Lyon, France, 69317
        • 039
      • Marseille, France, 13385
        • 045
      • Montpelier, France, 34295
        • 158
      • Nice, France, 06202
        • 037
      • Paris, France, 75571
        • 042
      • Paris, France, 75651
        • 044
      • Paris, France, 92118
        • 035
      • Strasbourg, France, 67098
        • 038
      • Toulouse, France, 31054
        • 033
      • Villejuif, France, 94804
        • 034
  • Germany
      • Berlin, Germany, 13353
        • 056
      • Erlangen, Germany, 91054
        • 058
      • Frankfurt, Germany, 60559
        • 051
      • Gottingen, Germany, 37099
        • 055
      • Hannover, Germany, 30625
        • 057
      • Jena, Germany, 07747
        • 142
      • Kiel, Germany, 24105
        • 053
      • Leipzig, Germany, 4103
        • 054
      • Mainz, Germany
        • Site: 156
      • Munster, Germany, 48149
        • 052
      • Regensberg, Germany, 93042
        • 060
      • Tubingen, Germany, 72076
        • 059
  • Hungary
      • Budapest, Hungary, 1082
        • 061
  • Ireland
      • Dublin, Ireland, 4
        • 070
  • Italy
      • Bergamo, Italy, 24122
        • 073
      • Bologna, Italy, 40138
        • 075
      • Genova, Italy, 16132
        • 076
      • Naples, Italy, 80131
        • 077
      • Naples, Italy, 80131
        • 079
      • Padova, Italy, 35127
        • 072
      • Rome, Italy, 144
        • 074
      • Udine, Italy, 33100
        • 071
  • Mexico
      • Mexico City, Mexico
        • Site: 166
  • Poland
      • Warsaw, Poland, 02-097
        • 086
      • Warsaw, Poland, 2006
        • 087
  • Romania
      • Bucharest, Romania, 22328
        • 091
  • Russian Federation
      • Moscow, Russian Federation, 123182
        • 096
      • Moscow, Russian Federation, 129090
        • 097
  • South Africa
      • Johannesburg, South Africa
        • 148
  • Spain
      • A Coruna, Spain, 15006
        • 114
      • Barcelona, Spain, 08036
        • 109
      • Barcelona, Spain, 08907
        • 106
      • Barcelona, Spain, 8035
        • 110
      • Madrid, Spain, 28034
        • 115
      • Madrid, Spain, 28041
        • 108
      • Madrid, Spain, 28222
        • 117
      • Zaragoza, Spain, 50009
        • 116
  • Sweden
      • Gothenberg, Sweden, 41345
        • 126
  • Switzerland
      • Zurich, Switzerland, 8091
        • 131
  • United Kingdom
      • Birmingham, United Kingdom, Bi5 2TH
        • 136
      • Leeds, United Kingdom, LS9 7TF
        • 171
      • London, United Kingdom, SE5 9RS
        • 138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dosing Regimen 1
Advagraf + MMF + Corticosteroids (Bolus)
Drug: Advagraf
Capsule
Other Names:
  • FK506E
  • MR4
  • 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:
  • FK506E
  • MR4
  • tacrolimus modified release
Drug: Mycophenolate Mofetil
Solution for infusion
Other Names:
  • MMF
Drug: Corticosteroids
IV bolus
Other Names:
  • Methylprednisolone or equivalent
Drug: Basiliximab
IV infusion
Other Names:
  • Simulect
Experimental: Dosing Regimen 3
Advagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus)
Drug: Advagraf
Capsule
Other Names:
  • FK506E
  • MR4
  • tacrolimus modified release
Drug: Mycophenolate Mofetil
Solution for infusion
Other Names:
  • MMF
Drug: Corticosteroids
IV bolus
Other Names:
  • Methylprednisolone or equivalent
Drug: Basiliximab
IV infusion
Other Names:
  • Simulect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks
GFR at 24 Weeks after transplantation measured by Iothalamate clearance
Time Frame: 24 weeks
24 weeks
GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula
Time Frame: 24 weeks
24 weeks
Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula
Time Frame: 24 weeks
24 weeks
Incidence of and time to first incidence of acute rejection
Time Frame: 24 weeks
24 weeks
Incidence of and time to first incidence of corticosteroid-resistant acute rejection
Time Frame: 24 weeks
24 weeks
Overall frequency of acute rejection episodes
Time Frame: 24 weeks
24 weeks
Incidence of and time to first incidence of biopsy confirmed acute rejection
Time Frame: 24 weeks
24 weeks
Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection
Time Frame: 24 weeks
24 weeks
Overall frequency of biopsy confirmed acute rejection episodes
Time Frame: 24 weeks
24 weeks
Severity of biopsy confirmed acute rejection episodes
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2009

Primary Completion (Actual)

January 4, 2013

Study Completion (Actual)

January 4, 2013

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMR-EC-1106
  • 2008-002231-32 (EudraCT Number: EudraCT)
  • 2010-021075-89 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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