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

Novartis

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: Simulect®; Drug: Myfortic; Drug: Sandimmun Optoral; Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514514

CRAD001ADE13

2006-007021-32

Details and patient eligibility

About

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.

Enrollment: 802 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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802 participants in 3 patient groups

CNI standard regimen

Active Comparator group

Description:

Myfortic, Sandimmun Optoral and corticosteroids

Treatment:

Drug: Sandimmun Optoral

Drug: Myfortic

Drug: Simulect®

CNI free regimen

Experimental group

Description:

CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids

Treatment:

Drug: Sandimmun Optoral

Drug: Everolimus

Drug: Myfortic

CNI low regimen

Active Comparator group

Description:

CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Treatment:

Drug: Sandimmun Optoral

Drug: Everolimus