This is an open-label Phase 2a clinical study designed to evaluate the safety and efficacy of AVB-S6-500 in patients with IgA Nephropathy (IgAN). Approximately 24 patients will be enrolled. Several dose levels of AVB-S6-500 may be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
AVB-S6-500 is experimental drug
Moonshine Clinical Research
Doral, Florida, United States
Institute of Nephrology National Academy of Medical Science Ukraine
Kyiv, Ukraine
Incidence of Adverse Events (AEs)
Measured by the number of patients with AEs
Time frame: 14 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day.
Time frame: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day in the Subset of Patients With Baseline High Proteinuria.
Time frame: 12 weeks
The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment
Time frame: 12 weeks
The Effect of AVB-S6-500 on Proportion of Patients Who Had at Least a Decrease of 0.5 g/Day Proteinuria From Baseline to End of Treatment.
Time frame: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).
Time frame: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).
Time frame: 12 weeks
Incidence of Anti-drug Antibody (ADA)
The number of participants with anti-AVB-S6-500 antibodies
Time frame: 14 weeks
Titers of Anti-AVB-S6-500 Antibodies
Time frame: 14 weeks
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Apparent Terminal Half-life (t1/2) of AVB-S6-500
Time frame: 12 weeks
Maximum Observed Plasma Concentration of AVB-S6-500 (Cmax)
Time frame: 12 weeks
Area Under Time-concentration Curve (AUC)
Time frame: 12 weeks
Time of Maximum Observed AVB-S6-500 Concentration (Tmax)
Time frame: 12 weeks