Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
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ClinicalTrials.gov Identifier: NCT00284947 |
Recruitment Status :
Completed
First Posted : February 1, 2006
Last Update Posted : March 29, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Transplantation Adverse Effects | Drug: basiliximab Drug: MMF/EC-MPS Drug: Corticosteroids | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 2006 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Maintenance immunosuppression
40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)
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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:
Drug: Corticosteroids Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
Other Names:
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284947
Switzerland | |
Novartis | |
Basel, Switzerland |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00284947 |
Other Study ID Numbers: |
CCHI621A2402 |
First Posted: | February 1, 2006 Key Record Dates |
Last Update Posted: | March 29, 2017 |
Last Verified: | March 2017 |
Side effects calcineurin inhibitors maintenance basiliximab Kidney maintenance transplant |
Prednisone Prednisolone Methylprednisolone Basiliximab Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |
Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Immunosuppressive Agents Immunologic Factors |