Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant,

• treated with cyclosporine and corticosteroids as primary immunosuppression.

Exclusion Criteria:

• Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ

• Patients who have received an investigational drug within four weeks prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply.