Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-Term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

This study is ongoing, but not recruiting participants.

First Received: January 30, 2006 Last Updated: May 29, 2008 History of Changes

Sponsored by:	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	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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: Mycophenolic acid 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

Secondary Outcome Measures:

to evaluate the risk of sensitization against the chimeric antibody over 6 months
to assess the changes in renal parameters after CNI discontinuation
to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs
to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs
to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect

Estimated Enrollment:	30
Study Start Date:	January 2006

Eligibility

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

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:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00284947 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Novartis:

Side effects, calcineurin inhibitors, maintenance phase after kidney transplantation, basiliximab
Kidney maintenance transplant

Study placed in the following topic categories:

Anti-Bacterial Agents
Basiliximab
Immunologic Factors
Mycophenolic Acid
Immunosuppressive Agents

Additional relevant MeSH terms:

Basiliximab
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Mycophenolic Acid
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009