Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

Novartis

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation

Treatments: Drug: everolimus; Drug: CNI; Drug: basiliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00378014

CRAD001HDE10

2005-002920-32

Details and patient eligibility

About

The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.

Enrollment: 276 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females 18 - 70 years old
• Liver transplant recipient (living or deceased donor)
• Patients in whom an allograft biopsy will not be contraindicated

Exclusion criteria

• Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
• HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
• HIV positive patients
• Patients who are breast feeding
• Patients with a current severe systemic infection
• Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
• Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
• Patients that have received Simulect prior to this study.
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

276 participants in 2 patient groups

Everolimus

Experimental group

Description:

Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice

Treatment:

Drug: basiliximab

Drug: CNI

Calcineurin Inhibitor (CNI)

Active Comparator group

Description:

Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Treatment:

Drug: basiliximab

Drug: everolimus

Drug: CNI