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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplantation Adverse Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

basiliximab

Intervention Type DRUG

40 mg once every 28 days intravenously for 24 weeks

MMF/EC-MPS

Intervention Type DRUG

1g MMF or 720mg EC-MPS p.o twice daily

Corticosteroids

Intervention Type DRUG

Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days

Interventions

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basiliximab

40 mg once every 28 days intravenously for 24 weeks

Intervention Type DRUG

MMF/EC-MPS

1g MMF or 720mg EC-MPS p.o twice daily

Intervention Type DRUG

Corticosteroids

Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days

Intervention Type DRUG

Other Intervention Names

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Simulect MPA Myfortic Cellcept Prednisone Methyl-prednisolone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No