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Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00859131
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE March 6, 2009
First Posted Date  ICMJE March 10, 2009
Results First Submitted Date  ICMJE May 14, 2015
Results First Posted Date  ICMJE April 26, 2016
Last Update Posted Date April 26, 2016
Study Start Date  ICMJE March 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant. [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
Treatment efficacy will be defined as the incidence of all biopsy proven acute rejection and calculated creatinine clearance using the abbreviated MDRD equation at one year post-transplant. [ Time Frame: One year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection. [ Time Frame: One year ]
  • Graft Survival at One Year Post-transplant [ Time Frame: 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 ]
  • Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers. [ Time Frame: One year ]
  • Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3 [ Time Frame: One year ]
  • Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3 [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
  • Evaluate the safety and tolerability of rabbit anti-thymocyte globulin or daclizumab in combination with tacrolimus, corticosteroids and mycophenolate mofetil. [ Time Frame: One year ]
  • Proportion of patients requiring antilymphocyte therapy for acute rejection. [ Time Frame: One year ]
  • Patient and graft survival at one year post-transplant [ Time Frame: One year ]
  • Incidence of post-transplant diabetes mellitus (PTDM), defined as post-discharge new need for insulin or oral hypoglycemic agents and meeting current ADA diagnostic criteria for diabetes mellitus [ Time Frame: 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 ]
  • Patient weight change [ Time Frame: one year ]
  • Incidence and severity of hypercholesterolemia (total cholesterol, HDL cholesterol, LDL cholesterol) and hypertriglyceridemia and treatment of hyperlipidemia, as defined in NCEP III guidelines [ Time Frame: One year ]
  • Incidence of post-transplant malignancies, including post-transplant lymphoproliferative disease (PTLD) and skin cancers. [ Time Frame: One year ]
  • Incidence of leukopenia, defined as a total white blood cell count of less than 2,000 cells/mm3 and neutropenia, defined as an absolute neutrophil count of less than 1,000 cells/mm3 and need for colony stimulating factors [ Time Frame: One year ]
  • Incidence of thrombocytopenia, defined as a platelet count of less than 100,000 cells/mm3 [ Time Frame: One year ]
  • Incidence of anemia, defined as a hemoglobin of less than 10 g/dL and need for erythropoietin or similar agents [ Time Frame: One year ]
  • Determine the impact of genotyping using microarray analysis on clinical outcomes and histologic findings [ Time Frame: One year ]
  • Utilizing the EuroQoL survey, determine if there is a correlation between graft function and quality of life [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists
Official Title  ICMJE Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE
  • Drug: Rabbit Antithymocyte globulin
    1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4
    Other Name: Thymoglobulin
  • Drug: Daclizumab
    1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
    Other Name: daclizumab, zenapax
Study Arms  ICMJE
  • Active Comparator: Thymoglobulin
    Subjects receiving Thymoglobulin as induction agent in renal transplantation
    Intervention: Drug: Rabbit Antithymocyte globulin
  • Active Comparator: Zenapax
    subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
    Intervention: Drug: Daclizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2009)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00859131
Other Study ID Numbers  ICMJE thymo vs IL2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Genzyme, a Sanofi Company
Investigators  ICMJE
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
PRS Account Medical University of South Carolina
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP