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Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

NCT01114529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 828

Last updated 2017-05-30

Study results available
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Summary

The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

Conditions

  • Kidney Transplantation

Interventions

DRUG

Everolimus

Early CNI to everolimus conversion

DRUG

Prograf or Neoral

Active CNI-based control (Prograf or Neoral)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-09
Primary Completion
2014-10-30
Completion
2014-10-30

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Estonia
  • France
  • Germany
  • Greece
  • India
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Russia
  • Spain
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT01114529 on ClinicalTrials.gov