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Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

NCT00270634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2013-02-12

Study results available
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Summary

This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

Conditions

Interventions

DRUG

Voclosporin

voclosporin 0.4, 0.6, 0.8 mg/kg po BID

DRUG

tacrolimus

tacrolimus 0.05 mg/kg po BID

Sponsors & Collaborators

  • Aurinia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Abramowicz, MD, PhD · Erasme hospital

  • Philip Belitsky, MD · No Affiliation

  • Arthur Matas, MD · University of Minnesota

  • Mark Pescovitz, MD · Indiana University

  • A. Osama Gaber, MD · The Methodist Hospital Research Institute

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
2006-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00270634 on ClinicalTrials.gov