Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.

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

Details

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

Criteria

Inclusion criteria

• Males or females, aged 18 - 70 years

• Recipients of de novo cadaveric, living unrelated or living related kidney transplants

• Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.

• Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

• More than one previous renal transplantation

• Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney

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

• Donor age: < 5 years or > 70 years

• Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)

• Other protocol-defined inclusion/exclusion criteria may apply