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Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00284947
First received: January 30, 2006
Last updated: March 27, 2017
Last verified: March 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Kidney Transplantation Adverse Effects | Drug: basiliximab Drug: MMF/EC-MPS Drug: Corticosteroids | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
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 [ Time Frame: 6 months ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 7 |
| Study Start Date: | January 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Maintenance immunosuppression
40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)
|
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:
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284947
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284947
Locations
| Switzerland | |
| Novartis | |
| Basel, Switzerland | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis | Novartis |
More Information
Additional Information:
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00284947 History of Changes |
| Other Study ID Numbers: |
CCHI621A2402 |
| Study First Received: | January 30, 2006 |
| Last Updated: | March 27, 2017 |
Keywords provided by Novartis:
|
Side effects calcineurin inhibitors maintenance basiliximab Kidney maintenance transplant |
Additional relevant MeSH terms:
|
Prednisone Methylprednisolone Mycophenolic Acid Basiliximab Mycophenolate mofetil 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 Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on August 23, 2017