Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00859131
First received: March 6, 2009
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
End Stage Renal Disease
Drug: Rabbit Antithymocyte globulin
Drug: Daclizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of rabbit anti-thymocyte globulin or daclizumab or basiliximab in combination with tacrolimus, corticosteroids and mycophenolate mofetil. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Proportion of patients requiring antilymphocyte therapy for acute rejection. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Patient and graft survival at one year post-transplant [ Time Frame: One year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient weight change [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of post-transplant malignancies, including post-transplant lymphoproliferative disease (PTLD) and skin cancers. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of thrombocytopenia, defined as a platelet count of less than 100,000 cells/mm3 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Incidence of anemia, defined as a hemoglobin of less than 10 g/dL and need for erythropoietin or similar agents [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Determine the impact of genotyping using microarray analysis on clinical outcomes and histologic findings [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Utilizing the EuroQoL survey, determine if there is a correlation between graft function and quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: daclizumab, zenapax

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859131

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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
  More Information

No publications provided by Medical University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00859131     History of Changes
Other Study ID Numbers: thymo vs IL2
Study First Received: March 6, 2009
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Antilymphocyte Serum
Daclizumab
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014