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

Phase 4TerminatedNCT00956293

Novartis Pharmaceuticals207 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

207

Conditions

Renal Transplantation

Interventions

BasiliximabDRUG

On day 0, 2 hours prior to transplant and day 4 post-transplant, 20 mg x2 were given to all participants. Post randomization, 20mg at weeks 7 and 12 were given to the Everolimus group.

Enteric Coated Mycophenolic Acid (MPA)DRUG

A loading dose regimen of 2880 mg/day during weeks 1 and 2 (pre-randomization) were given. During weeks 3 - 6 (pre-randomization), 2160 mg/day were given and during weeks 7 - 24, 1440 mg/day were given if tolerated. Dose reductions due to side effects were possible.

RAD001DRUG

Upon randomization, 3 mg (od) on Day 1, and 3 mg (1.5 mg every 12 hours) on Day 2 was given. Afterwards, the dosage was based on blood trough level (5 - 10 ng/mL).

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Düsseldorf, Germany

Novartis Investigative Site

Essen, Germany