Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation | Completed
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
DIAMOND
Trial Source

Health Conditions
  • Liver Transplantation
Completed
Recruitment Status
NCT01011205
Primary Trial ID Number
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.
Primary Outcome Measures
  • Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula; 24 weeks
Secondary Outcome Measures
  • 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; Incidence of and time to first incidence of corticosteroid-resistant acute rejection; 24 weeks; Overall frequency of acute rejection episodes; 24 weeks; Incidence of and time to first incidence of biopsy confirmed acute rejection; 24 weeks; Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection; 24 weeks; Overall frequency of biopsy confirmed acute rejection episodes; 24 weeks; Severity of biopsy confirmed acute rejection episodes; 24 weeks
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Argentina; Austria; Belarus; Belgium; Brazil; Canada; Colombia; Czech Republic; Denmark; Finland; France; Germany; Hungary; Ireland; Italy; Mexico; Norway; Poland; Romania; Russian Federation; South Africa; Spain; Sweden; Switzerland; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Drug; Advagraf; Capsule; [Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3]; Drug; Mycophenolate Mofetil; Solution for infusion; [Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3]; Drug; Basiliximab; IV infusion; [Dosing Regimen 2, Dosing Regimen 3]; Drug; Corticosteroids; IV bolus; [Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
DIAMOND
Scientific 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)
Secondary Trial Identifying Number
2008-002231-32; 2010-021075-89
Website
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp; https://astellasclinicalstudyresults-staging.azurewebsites.net/hcp/study.aspx?ID=PMR-EC-1106
Study Funded By
Astellas Pharma Inc
Funder Type
Sorry, this information is not available
Study Sponsored By
Astellas Pharma Inc
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

10 Nov 2009

Last Updated

12 Jun 2015

Date Record Refreshed on UKCTG

31 Jul 2015