Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar (NCT02546492) | Clinical Trial Compass
TerminatedPhase 4
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Stopped: Slow Enrollment
United States6 participantsStarted 2016-08
Plain-language summary
This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in patients with chronic antibody-mediated rejection (CAMR).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Age \>18 years
* Morphologic diagnosis of CAMR, by light \&/or electron microscopy any time after transplantation
* Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse peritubular capillary C4d staining by immunohistochemistry
* eGFR\>25 ml/min
Exclusion Criteria:
* Diagnosis of malignancy within a year prior to enrollment (except cured cutaneous basal cell or squamous cell carcinoma).
* Lack of evidence of antibody involvement
* Pregnancy, lactation, or refusal to use birth control in women of child bearing potential
* Active infection, or history of HIV
* History of liver or thoracic transplant