Single Dose rATG for Renal Allograft Rejection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2021-10-31

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.

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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.

Conditions

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Acute (Cellular) Renal Allograft Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard dose rATG

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

Group Type ACTIVE_COMPARATOR

rATG

Intervention Type DRUG

Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent \& treat acute rejection in organ transplantation

Single dose rATG

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

Group Type EXPERIMENTAL

rATG

Intervention Type DRUG

Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent \& treat acute rejection in organ transplantation

Interventions

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rATG

Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent \& treat acute rejection in organ transplantation

Intervention Type DRUG

Other Intervention Names

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Rabbit antithymocyte globulin Thymoglobulin ATG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No