Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients (CERTES02)

Novartis

Status and phase: Completed; Phase 3

Conditions: Organ Transplantation, Renal Transplantation

Treatments: Drug: Everolimus (Certican); Drug: Cyclosporine (Neoral); Drug: Steroid; Drug: Basiliximab (Simulect)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154284

CRAD001A2419

CRAD001A2423 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Full description

This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Enrollment: 114 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
• Renal cold ischemic time < 36 hours.
• Age of donor < 65 years.

Exclusion criteria

• Patients who have received an investigational drug within 4 weeks of baseline period.
• Patients who are recipients of multiple organ transplants, including any organ other than kidney.
• Recipients of non-heart beating donor organs.

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Everolimus (Certican) with Cyclosporine (Neoral) Continuation

Active Comparator group

Description:

Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.

Treatment:

Drug: Basiliximab (Simulect)

Drug: Steroid

Drug: Cyclosporine (Neoral)

Drug: Everolimus (Certican)

Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal

Experimental group

Description:

Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.

Treatment:

Drug: Basiliximab (Simulect)

Drug: Steroid

Drug: Cyclosporine (Neoral)

Drug: Everolimus (Certican)