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

NCT ID: NCT00154284

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-07-31

Brief Summary

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.

Detailed 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.

Conditions

Organ Transplantation, Renal Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus (Certican) with Cyclosporine (Neoral) Continuation

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.

Group Type: ACTIVE_COMPARATOR

Everolimus (Certican)

Intervention Type: DRUG

Cyclosporine (Neoral)

Intervention Type: DRUG

Steroid

Intervention Type: DRUG

Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.

Basiliximab (Simulect)

Intervention Type: DRUG

Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal

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.

Group Type: EXPERIMENTAL

Everolimus (Certican)

Intervention Type: DRUG

Cyclosporine (Neoral)

Intervention Type: DRUG

Steroid

Intervention Type: DRUG

Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.

Basiliximab (Simulect)

Intervention Type: DRUG

Interventions

Everolimus (Certican)

Intervention Type: DRUG

Cyclosporine (Neoral)

Intervention Type: DRUG

Steroid

Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.

Intervention Type: DRUG

Basiliximab (Simulect)

Intervention Type: DRUG

Other Intervention Names

Certican; Neoral; Prednisone; Simulect

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

novartis

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

References

Grinyo JM, Paul J, Novoa P, et al. (2010). Better renal function in renal-transplant recipients treated with everolimus plus cyclosporine elimination compared with cyclosporine minimisation, Am J Transplant; 10(Suppl 4): 503: Abstract 1636.

Reference Type: RESULT

Other Identifiers

CRAD001A2423

Identifier Type: OTHER

Identifier Source: secondary_id

CRAD001A2419

Identifier Type: -

Identifier Source: org_study_id

NCT00170807

Identifier Type: -

Identifier Source: nct_alias