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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance immunosuppression | Experimental | 40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| basiliximab | Drug | 40 mg once every 28 days intravenously for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Basel | Switzerland |
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| MMF/EC-MPS | Drug | 1g MMF or 720mg EC-MPS p.o twice daily |
|
|
| Corticosteroids | Drug | Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days |
|
|
| 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 |
| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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