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24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

NCT00555789 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2020-12-17

No results posted yet for this study

Summary

This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

Conditions

  • Kidney Transplantation

Interventions

DRUG

AEB071

200mg oral b.i.d.

DRUG

mycophenolic plus tacrolimus

720mg b.i.d. 2yrs

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

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 NCT00555789 on ClinicalTrials.gov