This double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR evaluates the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
Contact site for start date.
Please contact ClinicalResearch@sutterhealth.org about Study CSL Behring AMR.
View study details on ClinicalTrials.gov
Patients at least 18 years old with evidence of at least one DSA who has achieved a steady-state, post-transplant eGFR >40mL/min/1.73m2 or achieved a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant without dialysis, have biopsy-proven acute AMR per Banff 2015 criteria that is unresponsive to standard of care treatment are eligible for the study. Patients who have received over 2 weeks of dialysis before screening, have hepatobiliary disease, and active clinically significant bacterial or fungal infection are not eligible for this study.
June 01, 2018