Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients
Condition: Renal Transplant Rejection; Transplants and Implants
Intervention: Thymoglobulin; Thymoglobulin
Intervention description: Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF; Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine how safe and effective giving Thymoglobulin before transplantation to patients
      who are going to be receiving kidney transplants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult living donor renal transplant recipient.

          2. Patient is at least 18 years of age

          3. If female and of childbearing potential, have a negative serum or urine HCG within 24
             hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a
             medically approved method of birth control for the past 30 days prior to enrollment
             and agree to continue this practice during the 6 month efficacy analysis.

          4. Signed informed consent.

        Exclusion Criteria:

          1. Human Leukocyte Antibody (HLA) identical living donor transplant recipient.

          2. History of a positive cross-match with the donor.

          3. Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%.

          4. Patients who have previously received a kidney transplant.

          5. Active donor or recipient serology positive for human immunodeficiency virus (HIV),
             Hepatitis B virus (HBV), or Hepatitis C virus (HCV).

          6. History of noncompliance.

          7. History of chronic corticosteroid or immunosuppressive use except for inhaled
             corticosteroids to treat asthma. .

          8. Multiple organ transplant recipient.

          9. Patient with a urinary bladder that is absent or not functional (e.g. self
             catheterization) pretransplant.

         10. Patient who does not agree to use effective birth control during the 6-month efficacy
             analysis.

         11. Known contraindication to administration of rabbit antithymocyte globulin.

         12. Initial screening laboratory evaluations will be done locally before renal
             transplantation and the following laboratory values will be exclusionary: Platelets <
             100,000/mm23 or WBC < 3000/mm3

         13. Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high
             risk for poor compliance.

         14. Patient who, in the opinion of the investigator, has significant medical or
             psychosocial problems or unstable disease states that would preclude participation in
             the study. Examples of significant problems include, but are not limited to, morbid
             obesity or severe cardiac disease.

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