Clinical trial NCT02102854: Single Dose rATG for Renal Allograft Rejection
Official title: Single Dose rATG for Treatment of Acute Renal Allograft Rejection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute (Cellular) Renal Allograft Rejection
Keywords: kidney transplantation
acute rejection
rabbit antithymocyte globulin
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital length of hospitalization (days)
timeFrame: 7 days
Secondary outcomes:
measure: Infusion related symptoms
timeFrame: 7 days
Other outcomes:
measure: Rate of 30-day readmissions (%)
timeFrame: 30 days
measure: Incidence of leukopenia
timeFrame: 6 months
measure: Incidence of neutropenia (%)
timeFrame: 6 months
measure: Incidence of thrombocytopenia (%)
timeFrame: 6 months
measure: Incidence of BK viremia (%)
timeFrame: 6 months
measure: Incidence of cytomegalovirus (CMV) viremia (%)
timeFrame: 6 months
measure: Non-hematologic adverse events (%)
timeFrame: 6 months
measure: Clinical reversal of rejection
timeFrame: 6 months
measure: Time to reversal of rejection
timeFrame: 6 months
measure: Histological reversal of rejection
timeFrame: 6 months
measure: Kidney function status at 1, 3 and 6 months post-rejection treatment
timeFrame: 6 months
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Samir Patel, PharmD
role: PRINCIPAL_INVESTIGATOR
References: