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Single Dose rATG for Renal Allograft Rejection

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ClinicalTrials.gov Identifier: NCT02102854
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Samir J. Patel, The Methodist Hospital System

Tracking Information
First Submitted Date  ICMJE March 26, 2014
First Posted Date  ICMJE April 3, 2014
Last Update Posted Date September 3, 2020
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 1, 2020)
  • Rate of 30-day readmissions (%) [ Time Frame: 30 days ]
    Proportion of participants re-admitted to the hospital from discharge to day 30 for each group
  • 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 ]
    Number of days to reversal of rejection
  • Histological reversal of rejection [ Time Frame: 6 months ]
    Biopsy demonstrated absence of rejection if available
  • Kidney function status at 1, 3 and 6 months post-rejection treatment [ Time Frame: 6 months ]
    Serum creatinine at 1, 3 and 6 months post-rejection treatment
Original Other Pre-specified Outcome Measures
 (submitted: April 2, 2014)
  • 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
 
Descriptive Information
Brief Title  ICMJE Single Dose rATG for Renal Allograft Rejection
Official Title  ICMJE Single Dose rATG for Treatment of Acute Renal Allograft Rejection
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute (Cellular) Renal Allograft Rejection
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samir J Patel, Pharm.D. 713-441-2168 spatel2@houstonmethodist.org
Contact: Darrel W Cleere, RN, CCRP 713-441-6232 dwcleere@houstonmethodist.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02102854
Other Study ID Numbers  ICMJE Pro00003442
0809-0111 ( Other Identifier: HMRI IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samir J. Patel, The Methodist Hospital System
Study Sponsor  ICMJE The Methodist Hospital System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samir Patel, PharmD The Methodist Hospital System
PRS Account The Methodist Hospital System
Verification Date September 2020

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