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Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

NCT01586845 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-01-20

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.

Conditions

  • Renal Transplantation

Interventions

DRUG

voclosporin

Initial dose of voclosporin 0.8 mg/kg BID, then concentration controlled

DRUG

tacrolimus

tacrolimus as per labeled dose

Sponsors & Collaborators

  • Aurinia Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Entities

Drugs

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 NCT01586845 on ClinicalTrials.gov