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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:
ClinicalTrials.gov Identifier:
NCT00717470
First Posted: July 17, 2008
Last Update Posted: November 22, 2017
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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: 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)

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
Actual Study Start Date: May 14, 2008
Study Completion Date: March 2, 2010
Primary Completion Date: March 2, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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


  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 )
First Submitted: July 16, 2008
First Posted: July 17, 2008
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.
URL: http://

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

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
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