Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• Primary or secondary kidney transplant

• Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration [C0] ≥ 5.5 ng/mL)

• Creatinine clearance ≥ 30 mL/min and < 60 mL/min and stable renal function

Exclusion Criteria:

• Multi-organ recipients or previous transplant with any other organ different from kidney

• Biopsy proven acute rejection or treated acute rejection within the last 3 months.

• Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered

Other protocol-defined inclusion/exclusion criteria may apply.