Everolimus in de Novo Heart Transplant Recipients

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion criteria:

• Male or female cardiac transplant candidates 18-65 years of age undergoing primary heart transplantation.

• Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization

Exclusion criteria:

• Patients who are recipients of multiple solid organ transplants

• Patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive;

• Presence of Donor/Recipients serological mismatch for Hepatitis B or C;

• Recipients of organ from donors positive for Hepatitis B-surface antigen;

• Panel Reactive Antibodies (cytotoxicity method) > 30%.

• Other protocol-defined inclusion/exclusion criteria may apply