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

Phase 4

Completed

• Conditions: Adverse Effects; Kidney Transplantation
• Interventions: Drug: basiliximab; Drug: MMF/EC-MPS; Drug: Corticosteroids

• Registration Number: NCT00284947
• Lead Sponsor: Novartis

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 available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study First Posted: 2006-02-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maintenance immunosuppression	MMF/EC-MPS	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
Maintenance immunosuppression	Corticosteroids	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
Maintenance immunosuppression	basiliximab	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

Primary Outcome Measures

Name	Time	Method
to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels	6 months

Secondary Outcome Measures

Name	Time	Method
to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs	6 months
to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect	24 weeks
to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs	6 month
to assess the changes in renal parameters after CNI discontinuation	Month 1-6 post trasnplant
to evaluate the risk of sensitization against the chimeric antibody over 6 months	6 months

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland