A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab

This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

539

Phase

  • Phase 3

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

  • Australia
      • Adelaide, Australia, 5011
      • Sydney, Australia, 2050
  • Belgium
      • Bruxelles, Belgium, 1070
      • Leuven, Belgium, 3000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2R8
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
  • France
      • Vandoeuvre-les-nancy, France, 54511
  • Germany
      • Berlin, Germany, 13353
      • Hannover, Germany, 30625
      • Muenster, Germany, 48149
  • Mexico
      • Mexico City, Mexico, 06720
      • Monterrey, Mexico, 06720
  • Norway
      • Oslo, Norway, 0027
  • Poland
      • Warszawa, Poland, 02-006
      • Wroclaw, Poland, 50-417
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08907
      • Córdoba, Spain, 14004
      • Malaga, Spain, 29010
      • Santander, Spain, 39008
      • Valencia, Spain, 46009
  • Sweden
      • Goeteborg, Sweden, 41345
      • Malmoe, Sweden, 20502
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
      • Glasgow, United Kingdom, G11 6NT
      • Leicester, United Kingdom, LE5 4PW
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • San Francisco, California, United States, 94143
    • Florida
      • Gainesville, Florida, United States, 32610
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • New Jersey
      • Livingston, New Jersey, United States, 07039
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102-1192
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0777
    • Virginia
      • Falls Church, Virginia, United States, 22042-3300

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients greater than 18 years of age
  • recipients of primary kidney transplant
  • single-organ recipients (kidney only)

Exclusion Criteria:

  • previous treatment with Zenapax
  • history of malignancy (except localized skin cancer)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Corticosteroids
As prescribed
Drug: Neoral
Low dose (target trough level 50-100ng/mL)
Drug: Neoral
Standard dose (target trough level 150-300ng/mL)
Drug: Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
Drug: mycophenolate mofetil [CellCept]
1g po bid
Experimental: 2
Drug: Corticosteroids
As prescribed
Drug: Neoral
Low dose (target trough level 50-100ng/mL)
Drug: Neoral
Standard dose (target trough level 150-300ng/mL)
Drug: Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
Drug: mycophenolate mofetil [CellCept]
1g po bid
Experimental: 3
Drug: Corticosteroids
As prescribed
Drug: Neoral
Low dose (target trough level 50-100ng/mL)
Drug: Neoral
Standard dose (target trough level 150-300ng/mL)
Drug: mycophenolate mofetil [CellCept]
1g po bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function (as measured by GFR)
Time Frame: 12 months post-transplant
12 months post-transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient and graft survival \n
Time Frame: 12 months post-transplant
12 months post-transplant
Proportion of patients with biopsy-proven rejection; treatment failure.
Time Frame: 6 and 12 months post-transplant
6 and 12 months post-transplant
AEs, OIs, malignancies, deaths
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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

December 1, 2000

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

October 24, 2002

First Submitted That Met QC Criteria

October 24, 2002

First Posted (Estimate)

October 25, 2002

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M67005

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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