Single Dose rATG for Renal Allograft Rejection

Study Overview
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Brief Summary
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Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter.Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration including correlation to length of hospital stay and hospital costs.

Detailed Description
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Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter. This prolonged course is not consistent with the Medicare diagnosis-related group (DRG) for acute rejection which limits rejection admission to 3 days. The prolonged hospitalization results in increased medical costs and uniform financial loss to the hospital for patients admitted under this DRG. In addition there is a patient related toll of the prolonged hospitalization and a potential for additional hospital acquired complications. Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. The investigators hypothesize that single-dose rATG infusion will be as safe and efficacious as standard rATG administration when used for rejection treatment and would result in significant reduction in the length of hospital stay (LOS) and hospital costs for rejection treatment.

Official Title
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Single Dose rATG for Treatment of Acute Renal Allograft Rejection

Conditions
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Acute (Cellular) Renal Allograft Rejection

Intervention / Treatment
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* Drug: rATG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 18 years or older Experiencing a biopsy-proven acute rejection episode which: will require the use of rATG based on severity, or is exhibiting resistance to corticosteroid treatment, defined as failure of the serum creatinine to decrease after at least 3 days of corticosteroid treatment (≥200 mg/day of methylprednisolone or equivalent) Exclusion Criteria: Patients with known severe allergy to antithymocyte globulin or rabbits Rejection episode requiring the use of therapeutic plasma exchange immediately subsequent to rATG administration Currently receiving any investigational drug or treatments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose rATG<br>Standard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days | Drug: rATG<br>* Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent & treat acute rejection in organ transplantation<br>* Other names: ATG;|
| Experimental: Single dose rATG<br>Single dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration | Drug: rATG<br>* Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent & treat acute rejection in organ transplantation<br>* Other names: ATG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of hospitalization (days) | The length of hospitalization for treatment of renal allograft rejection in days will be determined which should be an average of 5-7 days | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infusion related symptoms | Incidence of grade 1, 2, or 3 infusion-related symptoms, graded according to common terminology criteria will be determined during the patient's hospital admission, which should be an average of 5-7 days | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, acute rejection, rabbit antithymocyte globulin