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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01011205
First received: November 10, 2009
Last updated: June 12, 2015
Last verified: June 2015
  Purpose
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 Intervention Phase
Liver Transplantation Drug: Advagraf Drug: Mycophenolate Mofetil Drug: Basiliximab Drug: Corticosteroids Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula [ Time Frame: 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) [ Time Frame: 24 weeks ]
  • GFR at 24 Weeks after transplantation measured by Iothalamate clearance [ Time Frame: 24 weeks ]
  • GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula [ Time Frame: 24 weeks ]
  • Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula [ Time Frame: 24 weeks ]
  • Incidence of and time to first incidence of acute rejection [ Time Frame: 24 weeks ]
  • Incidence of and time to first incidence of corticosteroid-resistant acute rejection [ Time Frame: 24 weeks ]
  • Overall frequency of acute rejection episodes [ Time Frame: 24 weeks ]
  • Incidence of and time to first incidence of biopsy confirmed acute rejection [ Time Frame: 24 weeks ]
  • Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection [ Time Frame: 24 weeks ]
  • Overall frequency of biopsy confirmed acute rejection episodes [ Time Frame: 24 weeks ]
  • Severity of biopsy confirmed acute rejection episodes [ Time Frame: 24 weeks ]

Enrollment: 893
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MMF
Drug: Corticosteroids
IV bolus
Other Name: 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 Name: MMF
Drug: Basiliximab
IV infusion
Other Name: Simulect
Drug: Corticosteroids
IV bolus
Other Name: Methylprednisolone or equivalent
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 Name: MMF
Drug: Basiliximab
IV infusion
Other Name: Simulect
Drug: Corticosteroids
IV bolus
Other Name: Methylprednisolone or equivalent

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011205

  Show 72 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Global Development - EU
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01011205     History of Changes
Other Study ID Numbers: PMR-EC-1106
2008-002231-32 ( Other Identifier: EudraCT )
2010-021075-89 ( EudraCT Number )
Study First Received: November 10, 2009
Last Updated: June 12, 2015

Keywords provided by Astellas Pharma Inc:
Advagraf
Liver
Transplant
Immunosuppression

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Basiliximab
Antibodies, Monoclonal
Methylprednisolone
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on June 27, 2017