Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Recipients of cadaveric kidney transplants

• Patients at risk of DGF defined as one or more of the following:

• Donor age > 55 years

• Cold ischemic time (CIT) ≥ 24 hours but < 40 hours

• Second or subsequent renal transplantation

Exclusion Criteria:

• Patients who have received an investigational drug within 4 weeks of baseline period

• Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney

• Patients with body mass index (BMI) > 32 kg/m2

Other protocol-defined exclusion criteria may apply.