Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation
Condition: End-Stage Renal Disease; Kidney Failure
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency
Intervention: Single-dose rabbit Anti-thymocyte Globulin induction; Divided-dose rabbit Anti-thymocyte Globulin induction
Intervention description: 6 mg of rATG administered in a single dose on the day of kidney transplantation; 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Renal transplantation; Kidney transplantation

Summary:

      In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence
      was found that a single large dose of Thymoglobulin on the day of kidney transplantation
      produced better kidney function than the standard dosing plan, when the same amount is
      divided into smaller doses on 4 days. This new study repeats that dose comparison, but with
      double-blinding and at multiple transplantation centers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject capable of giving written informed consent, with end-stage kidney disease, who
             is a suitable candidate for primary kidney transplantation

          -  Male or female subject who has reached legal age in the state where they reside and is
             at least 18 years of age

          -  Deceased or living donors

          -  Compatible ABO blood type

          -  Expanded-criteria donor (ECD) kidneys with a donor grade score of ≤ 25 (as developed
             by Nyberg, et al.)

          -  If Kidneys are pumped, they must meet the following pumping parameters: resistance
             <0.35 with a flow rate of >60 ml/min.

        Exclusion Criteria:

          -  Recipient age >65 years

          -  PRA >50%, or donor-specific antibody

          -  CIT >30 hours

          -  Re-transplant patients

          -  Multi-organ transplant recipients (example: kidney/pancreas or kidney/liver)

          -  Renal transplant recipients planned for future pancreas transplantation

          -  Current unstable cardiovascular disease or history of myocardial infarction within the
             previous 6 months

          -  Current malignancy or history or malignancy (within the previous 5 years) with the
             exception of non-metastatic basal or squamous cell carcinoma of the skin or carcinoma
             in-situ of the cervix that has been treated successfully.

          -  Hepatitis B and C recipients or active liver disease

          -  HIV positive recipients

          -  Primary disease requiring treatment with steroids after transplantation

          -  Expanded-criteria donor kidneys (current UNOS criteria) with a donor grade score of >
             25

          -  Donation after cardiac death (DCD) donors

          -  Dual adult kidneys

          -  Recipients of pediatric (age <12 years) unilateral or en-bloc kidneys

          -  Previous treatment with rATG

          -  Known hypersensitivity, extensive exposure, or allergy to rabbits

          -  Pregnant

          -  Any condition that in the investigator's opinion may compromise study participation
             (e.g., history or likelihood of non-compliance with immunosuppression regimen,
             protocol visits, tests, and studies)

        Relative Exclusion Criteria:

          -  Patients with a BMI > 37 should be considered on an individual basis based on overall
             health and body habitus.