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

Astellas

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation

Treatments: Drug: Mycophenolate Mofetil; Drug: Corticosteroids; Drug: Basiliximab; Drug: Advagraf

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011205

2008-002231-32 (EudraCT Number)

2010-021075-89 (EudraCT Number)

PMR-EC-1106

Details and patient eligibility

About

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.

Enrollment: 893 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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893 participants in 3 patient groups

Dosing Regimen 1

Experimental group

Description:

Advagraf + MMF + Corticosteroids (Bolus)

Treatment:

Drug: Advagraf

Drug: Corticosteroids

Drug: Mycophenolate Mofetil

Dosing Regimen 2

Experimental group

Description:

Advagraf + MMF + Basiliximab + Corticosteroids (Bolus)

Treatment:

Drug: Basiliximab

Drug: Advagraf

Drug: Corticosteroids

Drug: Mycophenolate Mofetil

Dosing Regimen 3

Experimental group

Description:

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

Treatment:

Drug: Basiliximab

Drug: Advagraf

Drug: Corticosteroids

Drug: Mycophenolate Mofetil