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

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

Tracking Information

• First Submitted Date: January 30, 2006
• First Posted Date: February 1, 2006
• Last Update Posted Date: March 29, 2017
• Study Start Date: January 2006
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Kidney Transplantation
• Adverse Effects

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 15, 2009): 7
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT00284947
• Other Study ID Numbers: CCHI621A2402
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novartis
• Study Sponsor: Novartis
• Collaborators: Not Provided

Investigators

• Study Director: Novartis; Novartis

• PRS Account: Novartis
• Verification Date: March 2017