Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program (Senator)

Novartis

Status and phase

Terminated

Phase 4

Conditions

Renal Transplantation

Treatments

Drug: Enteric Coated Mycophenolic Acid (MPA)

Drug: RAD001

Drug: Corticosteroids

Drug: Basiliximab

Drug: Cyclosporin A (CsA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00956293

2008-005109-20

EudraCT-NO. 2008-005109-20

CRAD001ADE19

Details and patient eligibility

About

This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.

Enrollment

207 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients receiving a primary kidney from a donor aged > 65 years
In the Eurotransplant Senior Program
Recipients of de novo cadaveric kidney transplants

Exclusion criteria

Multi-organ recipients (e.g., kidney and pancreas)
Patients receiving a kidney from a non-heart beating donor
Patients who are recipients of A-B-O incompatible transplants
Patients with already existing antibodies against the HLA-type of the receiving transplant
Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
Patients with thrombocytopenia, with an absolute neutrophil count of < 1,500/mm³ or leucopenia or hemoglobin < 6 g/dL
Patients who are HIV, HCV RNA, or Hepatitis B surface antigen positive
Evidence of severe liver disease
Females at randomization who will be not considered post-menopausal

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

207 participants in 2 patient groups

Control group

Active Comparator group

Description:

During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.

Treatment:

Drug: Corticosteroids

Drug: Cyclosporin A (CsA)

Drug: Basiliximab

Drug: Enteric Coated Mycophenolic Acid (MPA)

Everolimus group

Experimental group

Description:

Treatment:

Drug: Corticosteroids

Drug: Cyclosporin A (CsA)

Drug: Basiliximab