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

Condition(s) targeted: Kidney Transplantation; Adverse Effects

Intervention: basiliximab (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

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.

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

Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: 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:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): 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.

Novartis, Basel, Switzerland

Starting date: January 2006
Last updated: May 29, 2008