Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alexion Pharmaceuticals, Inc.
Age
17–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Had biopsy-confirmed primary C3G
Had clinical evidence of ongoing disease based on significant proteinuria, attributable to C3G disease in the opinion of the Principal Investigator (PI), and present prior to study entry and confirmed during Screening
Was willing to comply with vaccination requirements.
You may not be if
Had a history or presence of any clinically relevant co-morbidities that would make the participant inappropriate for the study
Had ever received danicopan
Had more than 50% fibrosis or more than 50% of glomeruli with cellular crescents on the pre-treatment renal biopsy
Had an estimated glomerular filtration rate \<30 milliliters/minute/1.73 meters squared at the time of screening or at any time over the preceding 4 weeks
Was a renal transplant recipient or receiving renal replacement therapy
Had a history of a major organ transplant or hematopoietic stem cell/marrow transplant
Had evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary
Had other renal diseases that would interfere with interpretation of the study
Had been diagnosed with or showed evidence of hepatobiliary cholestasis
Females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration
Had a history of febrile illness, a body temperature \>38°Celsius, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration
Had evidence of human immunodeficiency virus, hepatitis B infection, or active hepatitis C infection at Screening
Had laboratory abnormalities at screening that, in the opinion of the PI, would make the participant inappropriate for the study
Clareo Health | A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
