MedTrace Logo

SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus

NCT00371826 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2013-08-19

Study results available
· View outcomes & findings →

Summary

The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will be compared to a third control group, who will receive treatment consisting of cyclosporine micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.

Conditions

  • Renal Transplanted Recipients

Interventions

DRUG

Everolimus (RAD001)

DRUG

Cyclosporine (Calcineurin Inhibitor (CNI))

DRUG

Methylprednisone/prednisone

DRUG

Mycophenolate sodium (MPA)

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00371826 on ClinicalTrials.gov