Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation (DIAMOND)
Tracking InformationStart Date ICMJE | October 2009 |
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Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: November 10, 2009) | Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT01011205 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: November 10, 2009) | - 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 ] [ Designated as safety issue: No ]
- GFR at 24 Weeks after transplantation measured by Iothalamate clearance [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Incidence of and time to first incidence of acute rejection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Incidence of and time to first incidence of corticosteroid-resistant acute rejection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Overall frequency of acute rejection episodes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Incidence of and time to first incidence of biopsy confirmed acute rejection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Overall frequency of biopsy confirmed acute rejection episodes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Severity of biopsy confirmed acute rejection episodes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation |
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Official Title ICMJE | 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) |
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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. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Liver Transplantation |
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Intervention ICMJE | |
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Study Arms / Comparison Groups | - Dosing Regimen 1: Experimental
Advagraf + MMF + Corticosteroids (Bolus) Interventions: - Drug: Advagraf
- Drug: Mycophenolate Mofetil
- Drug: Corticosteroids
- Dosing Regimen 2: Experimental
Advagraf + MMF + Basiliximab + Corticosteroids (Bolus) Interventions: - Drug: Advagraf
- Drug: Mycophenolate Mofetil
- Drug: Basiliximab
- Drug: Corticosteroids
- Dosing Regimen 3: Experimental
Advagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus) Interventions: - Drug: Advagraf
- Drug: Mycophenolate Mofetil
- Drug: Basiliximab
- Drug: Corticosteroids
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Recruitment InformationEstimated Enrollment ICMJE | 900 |
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Estimated Completion Date | December 2012 |
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Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | 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
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | Austria, Belarus, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT01011205 |
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Responsible Party | Disclosure Office Europe, Astellas Pharma Europe BV |
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Study ID Numbers ICMJE | PMR-EC-1106, EuraCT number 2008-002231-32 |
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Study Sponsor ICMJE | Astellas Pharma Inc |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Chair: | Use Central Contact | Astellas Pharma Global Development - EU | |
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Information Provided By | Astellas Pharma Inc |
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