Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®.

It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Basiliximab; Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• Patients receiving a primary renal graft from a deceased or living, related or unrelated donor and who require basiliximab induction therapy

• Cold ischemia time < 30 hours

Exclusion (Non inclusion) criteria:

• Patients undergoing multi-organ transplantation, including both kidneys, or who have previously undergone organ transplantation, including renal transplantation

• Patients receiving a graft from a non-heart-beating donor

• A-B-O incompatible graft or positive T cell crossmatch

• Patients receiving a graft from an expanded criteria donor according to the UNOS definition (donor older than 60 years or donor aged between 50 and 60 years and presence of at least 2 of the following factors: hypertension, serum creatinine concentration ≥ 132 µmol/mL, cardiovascular cause of death)

• Positive anti-HLA antibodies (Luminex) prior to transplantation

• Patients whose original renal disease was primary focal and segmental hyalinosis or was related to atypical hemolytic uremic syndrome

• EBV-negative patients receiving a graft from an EBV-positive donor (EBV D+R-)

Other protocol-defined inclusion/exclusion criteria may apply.