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Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

NCT00820911 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2017-02-24

No results posted yet for this study

Summary

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Conditions

  • Kidney Transplantation

Interventions

DRUG

cyclosporine (reduced exposure) / everolimus

twice daily

DRUG

AEB071 300 mg b.i.d. / everolimus

twice daily

DRUG

AEB071 200 mg b.i.d. / everolimus

twice daily

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
2008-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Colombia
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Singapore
  • Slovakia
  • Spain
  • Switzerland
  • Taiwan

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 NCT00820911 on ClinicalTrials.gov