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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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00284947
First received: January 30, 2006
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to evaluate the risk of sensitization against the chimeric antibody over 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • to assess the changes in renal parameters after CNI discontinuation [ Time Frame: Month 1-6 post trasnplant ] [ Designated as safety issue: Yes ]
  • to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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)

  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00284947     History of Changes
Other Study ID Numbers: CCHI621A2402
Study First Received: January 30, 2006
Last Updated: May 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
Side effects
calcineurin inhibitors
maintenance
basiliximab
Kidney maintenance transplant

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Basiliximab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 13, 2013