12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

• Status: Completed
• Trial end date: 2016-03-23
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Basiliximab; Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Patient who had received a primary or secondary kidney transplant

• Patients who were willing and from whom written informed consent was obtained

• kidney allograft with a cold ischemia time (CIT) < 30 hours

• negative pregnancy test prior to study enrollment

Exclusion Criteria:

--Multi-organ recipients

• former Graft loss due to immunological reasons

• Patients who received a kidney from a non-heart beating donor

• A-B-0 incompatible transplants

• a current Panel Reactive Antibody (PRA) level of > 20%

• existing antibodies against the HLA-type of the receiving transplant

• a known hypersensitivity/contraindication to any of the immunosuppressants

• Use of other investigational drugs

• Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 8 g/dL

• significant mental illness

• history of malignancy during the last five years

• HIV positive

• uncontrolled hypercholesterolemia or hypertriglyceridemia

• drug or alcohol abuse

• pregnant or breast feeding women