Acute (Cellular) Renal Allograft Rejection
Conditions
Keywords
kidney transplantation, acute rejection, rabbit antithymocyte globulin
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.
Interventions
DRUGrATG
Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent & treat acute rejection in organ transplantation
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of hospitalization (days) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infusion related symptoms | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of neutropenia (%) | 6 months | Incidence of neutropenia, graded according the to common terminology criteria |
| Incidence of thrombocytopenia (%) | 6 months | Incidence of thrombocytopenia, graded according the to common terminology criteria |
| Incidence of BK viremia (%) | 6 months | Incidence of BK viremia or nephropathy at 6 months |
| Incidence of cytomegalovirus (CMV) viremia (%) | 6 months | Incidence of CMV viremia or disease at 6 months |
| Rate of 30-day readmissions (%) | 30 days | Proportion of participants re-admitted to the hospital from discharge to day 30 for each group |
| Clinical reversal of rejection | 6 months | Clinical reversal of rejection, defined as the return of serum creatinine to pre-rejection creatinine |
| Time to reversal of rejection | 6 months | Number of days to reversal of rejection |
| Histological reversal of rejection | 6 months | Biopsy demonstrated absence of rejection if available |
| Kidney function status at 1, 3 and 6 months post-rejection treatment | 6 months | Serum creatinine at 1, 3 and 6 months post-rejection treatment |
| Non-hematologic adverse events (%) | 6 months | Non-hematologic adverse events (i.e. serum sickness) |
| Incidence of leukopenia | 6 months | Incidence leukopenia, graded according the to common terminology criteria |
Countries
United States
Contacts
Primary ContactSamir J Patel, Pharm.D.
Backup ContactDarrel W Cleere, RN, CCRP
Outcome results
None listed