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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00717470
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Prograf® Drug: Advagraf® Drug: Mycophenolate Mofetil Drug: Simulect Drug: methylprednisolone / prednisone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)
Actual Study Start Date : May 14, 2008
Actual Primary Completion Date : March 2, 2010
Actual Study Completion Date : March 2, 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Prograf + MMF + Steroids
oral
 Drug: Prograf®
oral
Other Names:
  • FK506
  • Tacrolimus

Drug: Mycophenolate Mofetil
oral
Other Name: MMF

Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids
Active Comparator: Advagraf (dose 1) + MMF + steroids
oral
 Drug: Advagraf®
oral
Other Names:
  • MR4
  • FK506XL
  • Tacrolimus extended release

Drug: Mycophenolate Mofetil
oral
Other Name: MMF

Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids
Active Comparator: Advagraf (dose 2) + MMF + steroids
oral
 Drug: Advagraf®
oral
Other Names:
  • MR4
  • FK506XL
  • Tacrolimus extended release

Drug: Mycophenolate Mofetil
oral
Other Name: MMF

Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids
Active Comparator: Advagraf + MMF + Basilixmab + steroids
oral
 Drug: Advagraf®
oral
Other Names:
  • MR4
  • FK506XL
  • Tacrolimus extended release

Drug: Mycophenolate Mofetil
oral
Other Name: MMF

Drug: Simulect
oral
Other Name: basiliximab

Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy failure rate [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Renal Function, acute rejection, Biopsy confirmed acute rejection [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717470


Locations
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Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Central Contact Astellas Pharma Europe B.V.
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00717470    
Other Study ID Numbers: PMR-EC-1210
2007-005376-13 ( EudraCT Number )
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Keywords provided by Astellas Pharma Inc:
Kidney
Prograf
Transplant
 Advagraf
Immunosuppression
FK506
Additional relevant MeSH terms:
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Mycophenolic Acid
Prednisone
Methylprednisolone
Tacrolimus
Basiliximab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
 Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents