Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

September 21, 2012 updated by: University of Wisconsin, Madison
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.

Exclusion Criteria:

  • Recipients of HLA-identical living-donor renal transplants;
  • PRA value >20% within 30 days of transplant;
  • GFR <40ml/min;
  • multi-organ transplant;

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
No Intervention: 1
Standard of Care CNI immunosuppression
Experimental: 2
Calcineurin inhibitor withdrawal
Drug: Calcineurin inhibitor withdrawal
stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Biopsy Proven Rejection
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Creatinine at 36 Months (End of Study)
Time Frame: 36 months +/- 60 days
36 months +/- 60 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
WBC
Time Frame: 36 months +/- 60 days
White Blood Cell count
36 months +/- 60 days

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Stuart Knechtle, MD, University of Wisconsin, Madison

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

May 1, 2003

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

September 21, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-125

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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