Single Dose rATG for Renal Allograft Rejection
- Registration Number
- NCT02102854
- Lead Sponsor
- The Methodist Hospital Research Institute
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard dose rATG rATG Standard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days Single dose rATG rATG Single dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration
- Primary Outcome Measures
Name Time Method Hospital length of hospitalization (days) 7 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
- Secondary Outcome Measures
Name Time Method Infusion related symptoms 7 days 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
Trial Locations
- Locations (1)
Houston Methodist Hospital
🇺🇸Houston, Texas, United States