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

Novartis

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation; Renal Transplantation

Treatments: Drug: Mycophenolate mofetil (MMF); Drug: Enteric Coated Mycophenolate Sodium (EC-MPS); Drug: Corticosteroids; Drug: Everolimus; Drug: Simulect; Drug: Cyclosporin A; Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01843348

CRAD001ADE44

2011-005238-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 612 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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612 participants in 3 patient groups

TAC+MPA

Active Comparator group

Treatment:

Drug: Mycophenolate mofetil (MMF)

Drug: Enteric Coated Mycophenolate Sodium (EC-MPS)

Drug: Tacrolimus

Drug: Simulect

Drug: Corticosteroids

TAC+Certican

Experimental group

Treatment:

Drug: Tacrolimus

Drug: Simulect

Drug: Corticosteroids

Drug: Everolimus

CycA+Certican

Experimental group

Treatment:

Drug: Cyclosporin A

Drug: Simulect

Drug: Corticosteroids

Drug: Everolimus