Single Dose rATG for Renal Allograft Rejection
Single Dose rATG for Treatment of Acute Renal Allograft Rejection
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 26, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedSeptember 3, 2020
September 1, 2020
7 years
March 26, 2014
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Infusion related symptoms
7 days
Other Outcomes (11)
Rate of 30-day readmissions (%)
30 days
Incidence of leukopenia
6 months
Incidence of neutropenia (%)
6 months
- +8 more other outcomes
Study Arms (2)
Standard dose rATG
ACTIVE COMPARATORStandard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days
Single dose rATG
EXPERIMENTALSingle dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration
Interventions
Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent \& treat acute rejection in organ transplantation
Eligibility Criteria
You may qualify if:
- Male or female subjects aged 18 years or older
- 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)
You may not qualify if:
- Patients with known severe allergy to antithymocyte globulin or rabbits
- Rejection episode requiring the use of therapeutic plasma exchange immediately subsequent to rATG administration
- Currently receiving any investigational drug or treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Houston Methodist Hospital
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Samir Patel, PharmD
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Pharmacist
Study Record Dates
First Submitted
March 26, 2014
First Posted
April 3, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2021
Study Completion
October 1, 2021
Last Updated
September 3, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share