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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: IC-MPGN; C3 Glomerulopathy; IgA Nephropathy (IgAN)
• Intervention / Treatment: Drug: SGB-9768

Detailed Description

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
• Enrollment (Estimated): 38
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Medical mananger; Phone Number: +086 60209828; Email: lili.sheng@sanegenebio.com

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Changsha, China
    • The Third Xiangya Hospital of Central South University
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Guiyang, China
    • The Affiliated Hospital of Guizhou Medical University
  • Guiyang, China
    • Guizhou Provincial People's Hospital
  • Hangzhou, China
    • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Shanghai, China
    • Huashan Hospital
  • Yangzhou, China
    • Northern Jiangsu People's Hospital
  • Yinchuan, China
    • General Hospital of Ningxia Medical University
  • Zhengzhou, China
    • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IgAN-1; 2 doses of SGB-9768 by subcutaneous (sc) injection	Drug: SGB-9768; SGB-9768 for subcutaneous (SC) injection
Experimental: IgAN-2; 2 doses of SGB-9768 by subcutaneous (sc) injection	Drug: SGB-9768; SGB-9768 for subcutaneous (SC) injection
Experimental: C3G/IC-MPGN; 2 doses of SGB-9768 by subcutaneous (sc) injection	Drug: SGB-9768; SGB-9768 for subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in urine protein-creatinine ratio (UPCR)	24 weeks

Secondary Outcome Measures

Outcome Measure	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)		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

Collaborators and Investigators

• Sponsor: Suzhou Sanegene Bio Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: SGB-9768-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No