Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgAN-1 | Experimental | 2 doses of SGB-9768 by subcutaneous (sc) injection |
|
| IgAN-2 | Experimental | 2 doses of SGB-9768 by subcutaneous (sc) injection |
|
| C3G/IC-MPGN | Experimental | 2 doses of SGB-9768 by subcutaneous (sc) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGB-9768 | Drug | SGB-9768 for subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in urine protein-creatinine ratio (UPCR) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in UACR and 24h-urine protein | 24 weeks | |
| change from baseline in estimated glomerular filtration rate (eGFR) | 36 weeks | |
| Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical mananger | Contact | +086 60209828 | lili.sheng@sanegenebio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China | ||||
| Peking University People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| from erollment through week 36 |
| Pharmacokinetics-Cmax | Maximum Observed Plasma Concentration (Cmax) | 24 hours |
| Pharmacokinetics-Tmax | Time at which the maximum plasma concentration (Cmax) occurs | 24 hours |
| Pharmacokinetics-AUClast | Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration | 24 hours |
| Pharmacokinetics-t1/2 | Terminal Elimination Half-Life (t1/2) | 24 hours |
| Pharmacodynamics-C3 | Change From Baseline in serum Complement 3 (C3) level | baseline through week 36 |
| Pharmacodynamics-complement classical pathway activity by Wieslab® CP | Change From Baseline in serum Complement Classical Pathway Activity | baseline through week 36 |
| Pharmacodynamics-complement alternative pathway activity by Wieslab® AP | Change From Baseline in Serum Complement Alternative Pathway Activity | baseline through week 36 |
| Beijing |
| China |
| The Third Xiangya Hospital of Central South University | Changsha | China |
| 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 |
| Henan Provincial People's Hospital | Zhengzhou | China |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |