Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

March 23, 2016 updated by: Medical University of South Carolina

Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.

The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.

Study Type

Interventional

Enrollment (Actual)

200

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
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

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:

  • Male and female patients between 18 and 75 years of age
  • Male or female patients who are primary or repeat cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
  • The patient has given written informed consent to participate in the study

Exclusion Criteria:

  • Patient has previously received or is receiving an organ transplant other than a kidney.
  • Patients who are recipients of a multiple organ transplant.
  • Patient has received a primary or re-transplant from an HLA-identical living donor.
  • Any positive cross-match.
  • Patient is the recipient of a pediatric donor kidney from a pediatric donor aged 8 years or less.
  • Patient has received an ABO incompatible donor kidney.
  • Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
  • Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
  • Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
  • Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
  • Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
  • Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, daclizumab or corticosteroids.
  • Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
  • Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
  • Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
  • Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.
  • Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
  • Inability to cooperate or communicate with the investigator.

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: Thymoglobulin
Subjects receiving Thymoglobulin as induction agent in renal transplantation
Drug: Rabbit Antithymocyte globulin
1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4
Other Names:
  • Thymoglobulin
Active Comparator: Zenapax
subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Drug: Daclizumab
1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Other Names:
  • daclizumab, zenapax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.
Time Frame: One year
One year
Graft Survival at One Year Post-transplant
Time Frame: One year
One year
Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis
Time Frame: one year
one year
Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.
Time Frame: One year
One year
Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3
Time Frame: One year
One year
Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Study Chair: Kenneth D Chavin, MD,PhD, Medical University of South Carolina
  • Study Chair: Nicole Pilch, PharmD, Medical University of South Carolina
  • Study Chair: David Taber, PharmD, Medical University of South Carolina
  • Principal Investigator: Prabhakar Baliga, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • thymo vs IL2

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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