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

Novartis

Status and phase: Completed; Phase 4

Conditions: Renal Function

Treatments: Drug: corticosteroids; Drug: Basiliximab; Drug: Enteric Coated Mycophenolate Sodium (EC-MPS); Drug: everolimus; Drug: cyclosporine A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634920

CRAD001ASE01

2007-000771-42 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Everolimus (CNI-free)

Experimental group

Description:

Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart.

Treatment:

Drug: Enteric Coated Mycophenolate Sodium (EC-MPS)

Drug: everolimus

Drug: Basiliximab

Drug: corticosteroids

Control (CsA)

Active Comparator group

Description:

Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart.

Treatment:

Drug: cyclosporine A

Drug: Enteric Coated Mycophenolate Sodium (EC-MPS)

Drug: Basiliximab

Drug: corticosteroids