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| ID | Type | Description | Link |
|---|---|---|---|
| 0809-0111 | Other Identifier | HMRI IRB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose rATG | Active Comparator | Standard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days |
|
| Single dose rATG | Experimental | Single dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rATG | Drug | Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent & treat acute rejection in organ transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of hospitalization (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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Infusion related symptoms | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of 30-day readmissions (%) | Proportion of participants re-admitted to the hospital from discharge to day 30 for each group | 30 days |
| Incidence of leukopenia | Incidence leukopenia, graded according the to common terminology criteria |
Inclusion Criteria:
Male or female subjects aged 18 years or older
Experiencing a biopsy-proven acute rejection episode which:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samir J Patel, Pharm.D. | Contact | 713-441-2168 | spatel2@houstonmethodist.org | |
| Darrel W Cleere, RN, CCRP | Contact | 713-441-6232 | dwcleere@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Samir Patel, PharmD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
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| 6 months |
| Incidence of neutropenia (%) | Incidence of neutropenia, graded according the to common terminology criteria | 6 months |
| Incidence of thrombocytopenia (%) | Incidence of thrombocytopenia, graded according the to common terminology criteria | 6 months |
| Incidence of BK viremia (%) | Incidence of BK viremia or nephropathy at 6 months | 6 months |
| Incidence of cytomegalovirus (CMV) viremia (%) | Incidence of CMV viremia or disease at 6 months | 6 months |
| Non-hematologic adverse events (%) | Non-hematologic adverse events (i.e. serum sickness) | 6 months |
| Clinical reversal of rejection | Clinical reversal of rejection, defined as the return of serum creatinine to pre-rejection creatinine | 6 months |
| Time to reversal of rejection | Number of days to reversal of rejection | 6 months |
| Histological reversal of rejection | Biopsy demonstrated absence of rejection if available | 6 months |
| Kidney function status at 1, 3 and 6 months post-rejection treatment | Serum creatinine at 1, 3 and 6 months post-rejection treatment | 6 months |