IgA nephropathy, C3 glomerulopathy, and primary IC-MPGN
Conditions
Interventions
Queue 1:Received 100mg SGB-9768 injection on Day 1 and Day 85
Queue 2:Received 200mg SGB-9768 injection on Day 1 and Day 85
Queue 3:Received 200mg SGB-9768 injection on Day 1 and Day 85
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at the time of informed consent, male or female; 2. Body weight >=40 kg and body mass index (BMI) within the range of 15 to 35 kg/m^2 (inclusive of both endpoints) at the time of consent; 3. Renal biopsy within 5 years before screening with a diagnosis of primary IgA nephropathy, or renal biopsy within 1 year before screening a diagnosis of C3 glomerulopathy or IC-MPGN, with C3 deposition in the glomeruli; if renal biopsy was not performed within the time, a renal biopsy is required during the screening period to assess whether it meets the inclusion criteria; 4. UPCR >= 0.75 g/g at time of screening, and at the completion of the lead-in period, the baseline UPCR (the average of two 24-hour urine UPCR collected from day14 to day -1) >= 0.75 g/g; 5. Estimated glomerular filtration rate (eGFR) (calculated using CKD-EPI formula) >= 30 mL/min/1.73 m^2 at the time of screening and at the baseline assessment before the administration of investigational drug; 6. Have been receiving or willing to receive stable maximum tolerated dose of ACEI or ARB treatment for at least 12 weeks before the of the investigational drug; 7. Willing to receive meningococcal and pneumococcal vaccines according to the protocol requirements; 8. The subject and his partner agree to use effective contraception measures (such as hormonal contraceptives, condoms, inert intrauterine devices, etc.) from the time of signing the informed form to 3 months after the end of the study, or have already taken permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.); subjects have no plans to donate sperm from the time of signing the informed consent form to 3 months after the end of the study; 9. Fully understand the purpose requirements of this trial, voluntarily comply with the visit plan and requirements specified in the protocol, and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with renal biopsy pathology showing more than 50% tubular atrophy or interstitial fibrosis; 2. with renal biopsy pathology showing more than 50% crescent formation in glomeruli, or clinical manifestations suggesting possible rapidly progressive glomerulonephritis (GFR decline greater than 50% within 3 months); 3. Only applicable to IgAN: those with special types of IgA nephropathy pathological (assessed by the investigator), such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition; 4. Those with Ig nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases (assessed by the investigator): such as infection-related, autoimmune-related, monoclonal immunoglobulin-related, etc.; 5. Those with other systemic diseases or kidney diseases that may cause proteinuria (assessed by the investigator such as diabetic nephropathy, IgA vasculitis, lupus nephritis, minimal change nephropathy, post-infection glomerulonephritis etc.; 6. Those with rapid disease progression, defined as rapid decline in eGFR (eGFR decline > 10ml/min/1.7m^2 or > 20% in the 24 weeks before screening), assessed by the investigator (excluding those determined by the investigator to be caused by the of ACEI/ARB); 7. Those who are on dialysis at the time of screening or may require dialysis treatment during the study period; 8. Those who have received immunosuppressants or other immunomodulators within 90 days before the first administration the investigational drug, including but not limited to: cyclophosphamide, hydroxychloroquine, mycophenolate mofetil (F) or mycophenolate sodium, cyclosporine, tacrolimus, sirolimus, everolimus, or systemic exposure to corticoids (> 7.5 mg/day prednisone or other equivalent medications); ? For C3G and IC-MPGN subjects, the use of MMFor other mycophenolic acid-containing medications) and corticosteroid medications (prednisone = 20 mg/day or other equivalent medications) is; 9. Those who have received B-cell targeted biologics or other biologics within 180 days before the first administration of the investigational drug such as rituximab, infliximab, eculizumab, canakinumab; 10. Those who have received traditional Chinese medicine immunosuppressive effects within 90 days before the first administration of the investigational drug, such as Tripterygium wilfordii; 11. who have used mineralocorticoid receptor antagonists within 30 days before the first administration of the investigational drug; 12. Those who are using ST2 inhibitors, endothelin receptor antagonists, unless they have been on a stable dose for at least; 12 weeks before the administration of the investigational drug remain on a stable dose during the study; 13. Subjects with significant comorbidities, including but not limited to severe heart disease, severe lung disease, liver disease (e.g., active hepatitis) that, in the opinion of the investigator, would interfere with the subject's participation in the study; 14. Subjects a history of malignant neoplasm of any organ system within the past 5 years (excluding treated localized basal cell skin cancer or in situ cervical cancer), regardless of treatment was received, and regardless of whether there is evidence of local recurrence or metastasis; 15. Subjects with a history of severe trauma or major surgery within12 weeks prior to screening, or who plan to undergo surgery during the trial; 16. Subjects with type 1 or type 2 diabetes mellitus with pooremic control (HbA1c >= 7% at screenin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the 24-hour urine protein/creatinine ratio (UPCR) at 24 weeks after the first; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 24-hour urine albumin/creatinine ratio (24h-UACR) at 24 weeks after firsting;Change from baseline in 24-hour urine protein (24h-UP) at 24 weeks after first dosing;The change in 24h-UPCR from baseline;The change in 24h-UACR from baseline;The change in 24h-UP from baseline;The change from baseline in estimated glomerular filtration rate (eGFR) at 36 weeks after the first dose;Change from baseline in serum creatinine ;Changes in urine red blood cells from baseline;Cmax;Tmax;Serum C3 concentration; | — |
Countries
China
Contacts
Public ContactLv Jicheng
Peking University First Hospital
Outcome results
None listed