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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	7 participants
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

Arms and Interventions

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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 Name: 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

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:	Novartis	Novartis

More Information

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Additional Information:

Results for CCHI621A2402 from the Novartis Clinical Trials website. 

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00284947 History of Changes
Other Study ID Numbers:	CCHI621A2402
First Posted:	February 1, 2006
Last Update Posted:	March 29, 2017
Last Verified:	March 2017

Keywords provided by Novartis:

Side effects; calcineurin inhibitors; maintenance; basiliximab; Kidney maintenance transplant

Additional relevant MeSH terms:

Prednisone; Methylprednisolone; Mycophenolic Acid; Basiliximab; Antibodies, Monoclonal; Calcineurin Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunosuppressive Agents	Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antibiotics, Antineoplastic; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents; Anti-Infective Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents