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

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:

MedlinePlus related topics: Kidney Transplantation Steroids

Drug Information available for: Prednisone Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate mofetil Basiliximab

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations


Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis	Novartis

More Information


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:


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 Antibiotics, Antineoplastic Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents

ClinicalTrials.gov processed this record on September 30, 2016