APL-310 Protocol
The APL-310 study is what phase of Clinical Research?
Phase 3
An absolute neutrophil count <1000 cells/mm3 at screening is considered?
Exclusion Criteria
The Long-term safety and tolerability of pegcetacoplan is considered part of the?
What is Safety Endpoints
Sample already processed by local pathology laboratory are?
Historical Biopsy
The screening period is approximately how many weeks?
8 weeks.
No more than 50% global glomerulosclerosis or tubulointerstitial scarring on the baseline biopsy collected during screening is considered?
Inclusion Criteria
Assessing the safety of pegcetacoplan through incidence of treatment-emergent adverse events (TEAEs) is considered?
What is Secondary Objectives.
A critical secondary endpoint that needs to be scheduled far ahead as possible to mitigate last minute delays is?
Week 26 Biopsy
The total participation period for the APL-310 is?
84 Weeks
Patients that receive SC pegcetacoplan twice weekly for 26 weeks are part of what group?
Pegcetacoplan Group
The durability in uPCR reduction from Week 26 to Week 52 for patients randomized to the pegcetacoplan group is?
What is Additional Secondary Endpoint
The lab used to process renal biopsy for the study is?
Arkana Labs
Once all patients have completed week 26 visit, the data reported is known as?
Interim Analysis.
This is a Phase 3, randomized, placebo-controlled, double-blinded, multicenter study to evaluate the safety and efficacy of twice weekly SC infusions of pegcetacoplan in up to 88 patients diagnosed with primary C3G or IC-MPGN, at least 10 of whom have post-transplant recurrence of C3G or IC-MPGN.
Methodology
Patients with primary C3G or IC-MPGN, including those with post-transplant recurrence have a confirmed?
What is Diagnosis.
True or false: For adolescents, a historic biopsy is also required to allow central confirmation for diagnosis?
True
The infusion volume for subject ≥50kg is?
1080mg (20mL)
The 24 week follow up period (only for those subjects who do not roll into a long-term extension study) is what part of the study?
Part 4
The proportion of patients with at least a 50% reduction in uPCR relative to baseline at Week 26 is known as?
What is primary Efficacy
If biopsy was done within 28 weeks from randomization, it can be used to confirm?
Active Renal Disease