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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284947
• Other study ID #: CCHI621A2402
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2006
• Last updated: March 27, 2017
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effects
• Kidney Transplantation

Intervention

Drug:
• basiliximab
40 mg once every 28 days intravenously for 24 weeks
• MMF/EC-MPS
1g MMF or 720mg EC-MPS p.o twice daily
• Corticosteroids
Oral corticosteroids, equivalent to prednisone p.o, = 5mg daily or = 10mg on alternate days

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels		6 months
Secondary	to evaluate the risk of sensitization against the chimeric antibody over 6 months		6 months
Secondary	to assess the changes in renal parameters after CNI discontinuation		Month 1-6 post trasnplant
Secondary	to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs		6 months
Secondary	to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs		6 month
Secondary	to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect		24 weeks

External Links

•   Results for CCHI621A2402 from the Novartis Clinical Trials website.