A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection (OSAKA)

Astellas

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: methylprednisolone / prednisone; Drug: Mycophenolate Mofetil; Drug: Simulect; Drug: Advagraf®; Drug: Prograf®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717470

PMR-EC-1210

2007-005376-13 (EudraCT Number)

Details and patient eligibility

About

To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus

Enrollment: 1,252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
• Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
• Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study

Exclusion criteria

• Receiving or having previously received an organ transplant other than a kidney
• Cold ischemia time of the donor kidney > 30 hours
• Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
• Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
• Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
• Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
• Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
• Pregnant woman or breast-feeding mother
• 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
• 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
• Currently participating in another clinical trial, and/or has taken an investigational drug 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: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,252 participants in 4 patient groups

Prograf + MMF + Steroids

Active Comparator group

Description:

oral

Treatment:

Drug: Prograf®

Drug: methylprednisolone / prednisone

Drug: Mycophenolate Mofetil

Advagraf (dose 1) + MMF + steroids

Active Comparator group

Description:

oral

Treatment:

Drug: Advagraf®

Drug: methylprednisolone / prednisone

Drug: Mycophenolate Mofetil

Advagraf (dose 2) + MMF + steroids

Active Comparator group

Description:

oral

Treatment:

Drug: Advagraf®

Drug: methylprednisolone / prednisone

Drug: Mycophenolate Mofetil

Advagraf + MMF + Basilixmab + steroids

Active Comparator group

Description:

oral

Treatment:

Drug: Advagraf®

Drug: Simulect

Drug: methylprednisolone / prednisone

Drug: Mycophenolate Mofetil