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

Novartis

Status and phase

Completed

Phase 4

Conditions

Adverse Effects

Kidney Transplantation

Treatments

Drug: MMF/EC-MPS

Drug: Corticosteroids

Drug: basiliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00284947

CCHI621A2402

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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