Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Novartis Pharmaceuticals
Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m\^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301, Novartis FUB523, or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to \< 30 mL/min/1.73 m\^2. The exploratory cohort will be randomized using the same schema as the primary cohort. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on eGFR as measured by the change from Baseline in eGFR. Following completion of the 104-week treatment period, subjects may be eligible to enroll in an open-label extension (OLE) study to receive open-label treatment with BION-1301 under a separate protocol. Subjects who do not enroll in the OLE will enter the protocol-specified 24-week safety follow-up period. To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
