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

March 27, 2017 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Simulect
Drug: MMF/EC-MPS
1g MMF or 720mg EC-MPS p.o twice daily
Other Names:
  • Cellcept
  • Myfortic
  • MPA
Drug: Corticosteroids
Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
Other Names:
  • Prednisone
  • Methyl-prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
to evaluate the risk of sensitization against the chimeric antibody over 6 months
Time Frame: 6 months
6 months
to assess the changes in renal parameters after CNI discontinuation
Time Frame: Month 1-6 post trasnplant
Month 1-6 post trasnplant
to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs
Time Frame: 6 months
6 months
to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs
Time Frame: 6 month
6 month
to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHI621A2402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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