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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
Sponsor:
Information provided by (Responsible Party):
Novartis

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
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

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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, Older Adult)
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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Information from the National Library of Medicine

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


Locations
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Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Novartis
More Information
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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
Keywords provided by Novartis:
Side effects
calcineurin inhibitors
maintenance
basiliximab
Kidney maintenance transplant
Additional relevant MeSH terms:
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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