A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases
A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SGB-9768 in Patients with Primary IgA Nephropathy, C3 Glomerulopathy, and Immune Complex-mediated Membranoproliferative Glomerulonephritis.
1 other identifier
interventional
38
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2025
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 22, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 22, 2025
January 1, 2025
1.2 years
January 10, 2025
January 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline in urine protein-creatinine ratio (UPCR)
24 weeks
Secondary Outcomes (10)
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)
from erollment through week 36
Pharmacokinetics-Cmax
24 hours
Pharmacokinetics-Tmax
24 hours
- +5 more secondary outcomes
Study Arms (3)
IgAN-1
EXPERIMENTAL2 doses of SGB-9768 by subcutaneous (sc) injection
IgAN-2
EXPERIMENTAL2 doses of SGB-9768 by subcutaneous (sc) injection
C3G/IC-MPGN
EXPERIMENTAL2 doses of SGB-9768 by subcutaneous (sc) injection
Interventions
Eligibility Criteria
You may qualify if:
- Aged ≥18 years
- Weight ≥40 kg, with a body mass index (BMI) between 15 and 35 kg/m²
- Biopsy-confirmed diagnosis of primary IgA nephropathy, C3 glomerulopathy or IC-MPGN, accompanied by C3 deposition in the glomeruli.
- Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g
- Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) must be ≥30 mL/min/1.73 m².
- Must be on a stable maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks
- Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug
You may not qualify if:
- Kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis.
- Kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis.
- IgA nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases
- Presence of other systemic diseases or kidney diseases that may cause proteinuria
- Received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug
- Received B-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug
- Used SGLT2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more
- Significant comorbidities
- History of any malignant tumors of any organ system within the past 5 years
- History of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study.
- History of immunodeficiency diseases, congenital asplenia or splenectomy.
- History of recurrent invasive infections, active systemic bacterial, viral, or fungal infections
- Positive test results for HBV, HCV, HIV
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 2.5 times the upper limit of normal (ULN)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Peking University First Hospital
Beijing, China
Peking University People's Hospital
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2025
First Posted
January 22, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
January 22, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share