Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

NCT00133172 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2014-09-08

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Tacrolimus

IV

DRUG

mycophenolate mofetil

IV

DRUG

Prednisone

IV

Sponsors & Collaborators

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY
  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Canada, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Canada

Study Locations

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Entities

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 NCT00133172 on ClinicalTrials.gov