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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00284947

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Adverse Effects	Drug: basiliximab Drug: MMF/EC-MPS Drug: Corticosteroids	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: basiliximab 40 mg once every 28 days intravenously for 24 weeks Other Names: 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

Arm

Intervention/Treatment

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

Drug: basiliximab

40 mg once every 28 days intravenously for 24 weeks

Other Names:

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.