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Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

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: NCT00284947
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE February 1, 2006
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE January 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
  • to evaluate the risk of sensitization against the chimeric antibody over 6 months [ Time Frame: 6 months ]
  • to assess the changes in renal parameters after CNI discontinuation [ Time Frame: Month 1-6 post trasnplant ]
  • to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs [ Time Frame: 6 months ]
  • to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs [ Time Frame: 6 month ]
  • to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
Official Title  ICMJE REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
Brief Summary The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Kidney Transplantation
  • Adverse Effects
Intervention  ICMJE
  • Drug: basiliximab
    40 mg once every 28 days intravenously for 24 weeks
    Other Name: Simulect
  • Drug: MMF/EC-MPS
    1g MMF or 720mg EC-MPS p.o twice daily
    Other Names:
    • MPA
    • Myfortic
    • Cellcept
  • Drug: Corticosteroids
    Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
    Other Names:
    • Prednisone
    • Methyl-prednisolone
Study Arms  ICMJE Experimental: Maintenance immunosuppression

40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)

  • 1g MMF or 720mg EC-MPS p.o twice daily
  • Oral corticosteroids
Interventions:
  • Drug: basiliximab
  • Drug: MMF/EC-MPS
  • Drug: Corticosteroids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2009)
7
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
  • Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
  • Patients who are able to tolerate full dose MPA.
  • Patients with glomerular filtration rate (GFR) > 30 mL/min.
  • Patients without an acute rejection episode during the preceding 6 months.
  • Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.

Exclusion Criteria:

  • Patients with preformed positive skin test against basiliximab
  • Patients with preformed panel reactive antibody (PRA) > 10%.
  • Signs of active immune process on graft biopsy.
  • Patients with multi-organ or second kidney transplant

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00284947
Other Study ID Numbers  ICMJE CCHI621A2402
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Novartis
PRS Account Novartis
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP