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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00717470
First received: July 16, 2008
Last updated: June 12, 2015
Last verified: June 2015
  Purpose
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 Intervention Phase
Kidney Transplantation
Drug: Prograf®
Drug: Advagraf®
Drug: Mycophenolate Mofetil
Drug: Simulect
Drug: methylprednisolone / prednisone
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

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

Enrollment: 1252
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prograf + MMF + Steroids Drug: Prograf®
oral
Other Names:
  • Tacrolimus
  • FK506
Drug: Mycophenolate Mofetil
oral
Other Name: MMF
Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids
Active Comparator: Advagraf (dose 1) + MMF + steroids Drug: Advagraf®
oral
Other Names:
  • Tacrolimus extended release
  • MR4
  • FK506XL
Drug: Mycophenolate Mofetil
oral
Other Name: MMF
Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids
Active Comparator: Advagraf (dose 2) + MMF + steroids Drug: Advagraf®
oral
Other Names:
  • Tacrolimus extended release
  • MR4
  • FK506XL
Drug: Mycophenolate Mofetil
oral
Other Name: MMF
Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids
Active Comparator: Advagraf + MMF + Basilixmab + steroids Drug: Advagraf®
oral
Other Names:
  • Tacrolimus extended release
  • MR4
  • FK506XL
Drug: Mycophenolate Mofetil
oral
Other Name: MMF
Drug: Simulect
oral
Other Name: basiliximab
Drug: methylprednisolone / prednisone
oral
Other Name: corticosteroids

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: NCT00717470

  Show 110 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00717470     History of Changes
Other Study ID Numbers: PMR-EC-1210
2007-005376-13 ( EudraCT Number )
Study First Received: July 16, 2008
Last Updated: June 12, 2015

Keywords provided by Astellas Pharma Inc:
Kidney
Transplant
Immunosuppression
Advagraf
Prograf
FK506

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Tacrolimus
Mycophenolate mofetil
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on March 27, 2017