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

October 24, 2013 updated by: Rita Alloway, University of Cincinnati

An Open-Label, Comparative Trial of Two Daclizumab Dosing Strategies Versus No Induction Treatment in Combination With Tacrolimus, Mycophenolate Mofetil, and Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto Hospital
  • United States
    • California
      • Davis, California, United States, 95616
        • University of California - Davis
      • Los Angeles, California, United States, 90095
        • University of California - Los Angeles
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital
    • Florida
      • Miami, Florida, United States, 33124
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60208
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Ithaca, New York, United States, 14853
        • Cornell University
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolina Medical Center
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas - Houston
      • Waco, Texas, United States, 76798
        • Baylor University
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Medical College of Virginia
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Simultaneous kidney/pancreas transplant recipients
  • Insulin dependent Type 1 or 2 diabetes pretransplant
  • Recipient age 18-65 years
  • Donor age 5-65 years
  • Women must have negative serum pregnancy test and practice birth control for study duration
  • Negative T-cell crossmatch
  • Parent (or guardian) is able to understand the consent form and give written informed consent

Exclusion Criteria:

  • Prior treatment with daclizumab
  • Known sensitivity or contraindication to tacrolimus, MMF, or steroids
  • Patient with significant or active infection
  • Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
  • Patients whose life expectancy is severely limited by diseases other than renal disease
  • Ongoing substance abuse, drug or alcohol
  • Major ongoing psychiatric illness or recent history of noncompliance
  • Insufficient cardiovascular reserve
  • Malignancy within last 5 years, excluding nonmelanoma skin cancers
  • Serologic evidence of infection with HIV or Hepatitis B surface antigen positive
  • Investigational drug within 30 days prior to transplant surgery
  • Anti-T cell therapy within 30 days prior to transplant surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 5 Dose Daclizbumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Drug: Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
ACTIVE_COMPARATOR: 2 Dose Daclizaumab
daclizumab 2 mg/kg/dose every 14 days for 2 doses
Drug: Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
ACTIVE_COMPARATOR: Control
no antibody induction
Drug: Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant.

Secondary Outcome Measures

Outcome Measure
Incidence, timing and severity of fungal infections.
Incidence, timing and severity of malignancies.
Hospitalizations.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Roche Pharma AG
University of Tennessee

Investigators

  • Principal Investigator: Robert J Stratta, MD, University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion (ACTUAL)

December 1, 2004

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEN049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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