Recruiting

rATG

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT02102854

Conditions

Acute (Cellular) Renal Allograft Rejection

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

rATG

Study Details

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.

Conditions

Acute (Cellular) Renal Allograft Rejection

Study ID

NCT02102854

Start date

Mar, 2014

Status verified date

Sep, 2020

Completion date

Oct, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard dose rATG

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

experimental: Single dose rATG

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

Interventions

rATG

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

Primary outcome measure

  • Hospital length of hospitalization (days) [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Samir J Patel, Pharm.D.

713-441-2168spatel2@houstonmethodist.org

Darrel W Cleere, RN, CCRP

713-441-6232dwcleere@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Darrel W Cleere, RN, CCRC

713-441-6232dwcleere@houstonmethodist.org

Principal Investigator:

Samir J Patel, Pharm.D.

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Sep 3, 2020

Last verified

Sep, 2020

Keywords

  • kidney transplantation
  • acute rejection
  • rabbit antithymocyte globulin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2020-09-03.