Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients

Novartis

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation; Graft Rejection

Treatments: Drug: Corticosteroids; Drug: Everolimus; Drug: Basiliximab; Drug: Mycophenolic Acid (MPA); Drug: Cyclosporine A (CsA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00251004

CRAD001A2309

Details and patient eligibility

About

The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.

Enrollment: 833 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients of any race between 18 to 70 years old (inclusive)
• Patients who gave written informed consent to participate in the study

Exclusion criteria

• Recipients of multi-organ transplantation
• Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
• Graft cold ischemia time greater than 40 hours.

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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833 participants in 3 patient groups

Low-dose Everolimus Group

Experimental group

Description:

1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids. The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.

Treatment:

Drug: Cyclosporine A (CsA)

Drug: Basiliximab

Drug: Everolimus

Drug: Corticosteroids

High-dose Everolimus Group

Experimental group

Description:

3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids. The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.

Treatment:

Drug: Cyclosporine A (CsA)

Drug: Basiliximab

Drug: Everolimus

Drug: Corticosteroids

Control Group

Active Comparator group

Description:

1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids. The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.

Treatment:

Drug: Cyclosporine A (CsA)

Drug: Mycophenolic Acid (MPA)

Drug: Basiliximab

Drug: Corticosteroids