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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:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00717470
First received: July 16, 2008
Last updated: March 23, 2010
Last verified: March 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Efficacy failure rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal Function, acute rejection, Biopsy confirmed acute rejection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1252
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: February 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
Genders Eligible for Study:   Both
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
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 BV
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00717470     History of Changes
Other Study ID Numbers: PMR-EC-1210, 2007-005376-13
Study First Received: July 16, 2008
Last Updated: March 23, 2010
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Ministry of Social Affairs, Public Health and the Environment
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ethics Committee
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Basiliximab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013