Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Transplantation

Treatments: Drug: Steroids; Drug: Everolimus + Cyclosporine; Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00425308

CRAD001AFR06

Details and patient eligibility

About

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who participated in and completed study CRAD001A2420

Exclusion criteria

• Premature study or study treatment discontinuation in CRAD001A2420 study.
• Acute rejection within the 3 months prior to inclusion

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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30 participants in 2 patient groups

Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Active Comparator group

Description:

Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Treatment:

Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Drug: Steroids

Everolimus + Cyclosporine

Active Comparator group

Description:

Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids

Treatment:

Drug: Steroids

Drug: Everolimus + Cyclosporine