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Single Dose rATG for Acute Renal Allograft Rejection
NCT02102854Phase 4
Key facts
- Status
- Unknown
- Start
- Mar 2014
- Primary completion
- Mar 2021
- Countries
- 1
- Sponsor
- Houston Methodist Research Institute
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Conditions
- kidney transplant rejection
01
Overview
Phase 4, randomised, open-label trial of antithymocyte globulin in kidney transplant rejection (2 arms), sponsored by Houston Methodist Research Institute. Primary endpoint: Hospital length of hospitalization at 7 days. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard dose rATG
Daily infusions of 1.5 mg/kg x 4-5 days
Single dose rATG
2 consecutive 3 mg/kg IV infusions over 24-36 hours
03
Who it enrols
Adult patients with biopsy-proven acute renal allograft rejection requiring rATG or resistant to corticosteroids.
04
Endpoints
Primary
Hospital length of hospitalization
Secondary
Infusion related symptoms
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