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Single Dose rATG for Renal Allograft Rejection

This study is currently recruiting participants.
Verified March 2016 by Samir J. Patel, The Methodist Hospital System
Sponsor:
ClinicalTrials.gov Identifier:
NCT02102854
First Posted: April 3, 2014
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Samir J. Patel, The Methodist Hospital System
March 26, 2014
April 3, 2014
March 23, 2016
March 2014
March 2018   (Final data collection date for primary outcome measure)
Hospital length of hospitalization (days) [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT02102854 on ClinicalTrials.gov Archive Site
Infusion related symptoms [ Time Frame: 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
Same as current
  • Rate of 30-day readmissions (%) [ Time Frame: 30 days ]
  • Incidence of leukopenia [ Time Frame: 6 months ]
    Incidence leukopenia, graded according the to common terminology criteria
  • Incidence of neutropenia (%) [ Time Frame: 6 months ]
    Incidence of neutropenia, graded according the to common terminology criteria
  • Incidence of thrombocytopenia (%) [ Time Frame: 6 months ]
    Incidence of thrombocytopenia, graded according the to common terminology criteria
  • Incidence of BK viremia (%) [ Time Frame: 6 months ]
    Incidence of BK viremia or nephropathy at 6 months
  • Incidence of cytomegalovirus (CMV) viremia (%) [ Time Frame: 6 months ]
    Incidence of CMV viremia or disease at 6 months
  • Non-hematologic adverse events (%) [ Time Frame: 6 months ]
    Non-hematologic adverse events (i.e. serum sickness)
  • Clinical reversal of rejection [ Time Frame: 6 months ]
    Clinical reversal of rejection, defined as the return of serum creatinine to pre-rejection creatinine
  • Time to reversal of rejection [ Time Frame: 6 months ]
  • Histological reversal of rejection [ Time Frame: 6 months ]
  • Serum creatinine at 1, 3 and 6 months post-rejection treatment [ Time Frame: 6 months ]
    Serum creatinine at 1, 3 and 6 months post-rejection treatment
Same as current
 
Single Dose rATG for Renal Allograft Rejection
Single Dose rATG for Treatment of Acute Renal Allograft Rejection
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute (Cellular) Renal Allograft Rejection
Drug: rATG
Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent & treat acute rejection in organ transplantation
Other Names:
  • Rabbit antithymocyte globulin
  • Thymoglobulin
  • ATG
  • Active Comparator: Standard dose rATG
    Standard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days
    Intervention: Drug: rATG
  • 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
    Intervention: Drug: rATG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2018
March 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Samir J Patel, Pharm.D. 713-441-2168 spatel2@houstonmethodist.org
Contact: Darrel W Cleere, RN, CCRP 713-441-6232 dwcleere@houstonmethodist.org
United States
 
 
NCT02102854
Pro00003442
0809-0111 ( Other Identifier: HMRI IRB )
No
Not Provided
Plan to Share IPD: Undecided
Samir J. Patel, The Methodist Hospital System
The Methodist Hospital System
Not Provided
Principal Investigator: Samir Patel, PharmD The Methodist Hospital System
The Methodist Hospital System
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP