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A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

NCT00363116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2013-10-25

No results posted yet for this study

Summary

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.

Conditions

  • Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

Interventions

DRUG

Daclizumab

daclizumab 1 mg/kg/dose every 14 days for 5 doses

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • University of Tennessee

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Robert J Stratta, MD · University of Tennessee

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
1999-04-30
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • United States
  • Canada

Study Locations

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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 NCT00363116 on ClinicalTrials.gov