Single Dose rATG for Renal Allograft Rejection

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Unknown; Phase 4

Conditions: Acute (Cellular) Renal Allograft Rejection

Treatments: Drug: rATG

Study type: Interventional

Funder types: Other

Identifiers

NCT02102854

Pro00003442

0809-0111 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged 18 years or older

2. 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

1. Patients with known severe allergy to antithymocyte globulin or rabbits
2. Rejection episode requiring the use of therapeutic plasma exchange immediately subsequent to rATG administration
3. Currently receiving any investigational drug or treatments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard dose rATG

Active Comparator group

Description:

Standard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days

Treatment:

Drug: rATG

Single dose rATG

Experimental group

Description:

Single dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration

Treatment:

Drug: rATG