The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of Immunoglobulin A nephropathy (IgAN)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Percent change in proteinuria from Baseline to Week 24
Time frame: Baseline and Week 24
Number of participants who demonstrate a ≥30% reduction from Baseline in proteinuria
Time frame: Baseline, Week 8, Week 12, Week 18, and Week 24
Number of participants who reach and maintain proteinuria levels below 1.0 g/24 h
Time frame: Week 8, Week 12, Week 18, and Week 24
Mean change from Baseline in Estimated glomerular filtration rate (eGFR)
Time frame: Baseline, Week 8, Week 12, Week 18, and Week 24
Number of participants who experience any treatment-related serious adverse event (SAE) or severe adverse events (AE) during the course of the treatment period or subsequent follow-up period
Time frame: Throughout the study period of approximately 19 months
Number of participants who experience serious adverse events (SAEs) or adverse events (AEs)
Time frame: Throughout the study period of approximately 19 months
Number of participants who experience temporally-related adverse events (AEs)
Temporally-related AEs - defined as AEs occurring during investigational product (IP) administration or within 72 hours of IP administration, regardless of causality
Time frame: Baseline through 72 hours of IP administration
Number of participants with any clinically significant change in vital signs during investigational product (IP) administration or within 30 minutes following administration
Time frame: Baseline through 30 minutes following IP administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of infusions associated with adverse events (AEs) or serious adverse events (SAEs) , regardless of causality
Time frame: Throughout the study period of approximately 19 months
Number of infusions that had to be slowed, interrupted, or terminated due to adverse events (AEs) or serious adverse events (SAEs)
Time frame: Throughout the study period of approximately 19 months
Number of participants with detectable levels of antidrug antibodies (ADAs)
Time frame: Baseline, Week 3, Week 4, Week 12, Week 24, or early termination from the study
Clinically significant abnormal laboratory assessments
Time frame: Throughout the study period of approximately 19 months
Pharmacokinetics: maximum observed concentration (Cmax)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: time of maximum observed concentration (Cmax)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: area under the concentration-time curve during a dosing interval (AUC(0-tau))
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: terminal half-life (t1/2)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: systemic clearance (CL)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: volume of distribution at the terminal phase (Vz)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.
Pharmacokinetics: volume of distribution at steady state (Vss)
Time frame: Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.