This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.
This is a phase 2, multicenter, open-label study to evaluate of the efficacy and safety of SGB-9768 in patients with primary IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. The primary objective is to evaluate efficacy of SGB-9768 in reducing urine protein excretion and maintain kidney function in these patients. Secondly, safety, pharmacokinetics and pharmacodynamics will be charaterized.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
SGB-9768 for subcutaneous (SC) injection
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Third Xiangya Hospital of Central South University
Changsha, China
change from baseline in urine protein-creatinine ratio (UPCR)
Time frame: 24 weeks
change from baseline in UACR and 24h-urine protein
Time frame: 24 weeks
change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: 36 weeks
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Time frame: from erollment through week 36
Pharmacokinetics-Cmax
Maximum Observed Plasma Concentration (Cmax)
Time frame: 24 hours
Pharmacokinetics-Tmax
Time at which the maximum plasma concentration (Cmax) occurs
Time frame: 24 hours
Pharmacokinetics-AUClast
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
Time frame: 24 hours
Pharmacokinetics-t1/2
Terminal Elimination Half-Life (t1/2)
Time frame: 24 hours
Pharmacodynamics-C3
Change From Baseline in serum Complement 3 (C3) level
Time frame: baseline through week 36
Pharmacodynamics-complement classical pathway activity by Wieslab® CP
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Sichuan Provincial People's Hospital
Chengdu, China
Guizhou Provincial People's Hospital
Guiyang, China
The affiliated hospital of Guizhou medical university
Guiyang, China
The first affiliated hospital, Zhejiang university school of medicine
Hangzhou, China
Huashan hospital
Shanghai, China
Northern Jiangsu People's Hospital
Yangzhou, China
General hospital of ningxia medical university
Yinchuan, China
...and 1 more locations
Change From Baseline in serum Complement Classical Pathway Activity
Time frame: baseline through week 36
Pharmacodynamics-complement alternative pathway activity by Wieslab® AP
Change From Baseline in Serum Complement Alternative Pathway Activity
Time frame: baseline through week 36