A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients
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.
Location: CPMC (San Francisco)
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