Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Basiliximab; Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Sirolimus

Criteria

Inclusion Criteria:

• First or second single renal transplant from deceased or living donor

Exclusion criteria

• Recipient of organs other than a renal transplant

• Present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin

• Severe liver disease

• At the time of randomization 7 weeks after transplantation

In addition to the above criteria the following must be met at time of randomization:

Inclusion Criteria:

• Patients maintained on a triple immunosuppressive regime consisting of cyclosporine, Enteric coated mycophenolate, and corticosteroids

• Patients completed the first 7 weeks without experiencing any rejection

Exclusion Criteria:

• Graft loss

• Low hemoglobin value, low number of white blood cells or platelets

• High cholesterol values

• Proteinuria

• Wound healing problems

• Current severe major local or systemic infection

• Renal insufficiency

Other protocol-defined inclusion/exclusion criteria may apply.