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

Tracking Information

First Received Date ^ICMJE

January 30, 2006

Last Updated Date

October 15, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels

Change History

Complete list of historical versions of study NCT00284947 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Single Group Assignment

Condition ^ICMJE

Kidney Transplantation
Adverse Effects

Intervention ^ICMJE

Drug: basiliximab
Drug: MMF/EC-MPS
Drug: Corticosteroids

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00284947

Responsible Party

Novartis, Novartis

Study ID Numbers ^ICMJE

CCHI621A2402

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP