Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

January 11, 2010 updated by: University of Miami

Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-term Nephrotoxic Calcineurin Inhibitor Therapy

The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra).

To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.

To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.

Study Type

Interventional

Enrollment (Actual)

38

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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Jackson Memorial Hospital

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >14 years
  • Weight >40 kg
  • Primary renal allograft:living related (non HLA identical) and unrelated donor
  • Negative standard cross match for T-cells
  • Signed and dated consent form

Exclusion Criteria:

  • Patient has previously received or is receiving an organ transplant other than kidney
  • Patient has received a kidney transplant from a non-heart beating donor
  • Patient has received an ABO incompatible donor kidney
  • Recipient or donor is seropositive for human immunodeficiency virus (HIV)
  • Patient has a current malignancy or a history of malignancy

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1mg/kg Thymoglobulin
LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.
Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Names:
  • Thymoglobulin
  • Zenapax
Active Comparator: Campath-1H at 0.3 mg/kg
Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.
Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Names:
  • Thymoglobulin
  • Zenapax
Active Comparator: Zenapax 1 mg/kg
Recipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages.
Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Names:
  • Thymoglobulin
  • Zenapax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.
Time Frame: 3 years
3 years
Patient/graft survival.
Time Frame: 1 and 3 yrs.
1 and 3 yrs.

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse reactions.
Time Frame: 1 & 3 years.
1 & 3 years.

Collaborators and Investigators

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

Sponsor

University of Miami

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: George W Burke, M.D., University of Miami

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

November 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20010704

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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