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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00284947

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 IV

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment
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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Prednisone Mycophenolic acid Methylprednisolone Basiliximab Corticosteroids

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
Maintenance immunosuppression: Experimental 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 Drug: MMF/EC-MPS 1g MMF or 720mg EC-MPS p.o twice daily Drug: Corticosteroids Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days

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

More Information

No publications provided

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CCHI621A2402
Study First Received:	January 30, 2006
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00284947 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Neuroprotective Agents
Hormones

Therapeutic Uses
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Basiliximab
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009