A Study of SGB-9768 in Patients With Complement-mediated Kidney Diseases

September 3, 2026 updated by: Suzhou Sanegene Bio Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
change from baseline in urine protein-creatinine ratio (UPCR)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in UACR and 24h-urine protein
Time Frame: 24 weeks
24 weeks
change from baseline in estimated glomerular filtration rate (eGFR)
Time Frame: 36 weeks
36 weeks
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Time Frame: from erollment through week 36
from erollment through week 36
Pharmacokinetics-Cmax
Time Frame: 24 hours
Maximum Observed Plasma Concentration (Cmax)
24 hours
Pharmacokinetics-Tmax
Time Frame: 24 hours
Time at which the maximum plasma concentration (Cmax) occurs
24 hours
Pharmacokinetics-AUClast
Time Frame: 24 hours
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
24 hours
Pharmacokinetics-t1/2
Time Frame: 24 hours
Terminal Elimination Half-Life (t1/2)
24 hours
Pharmacodynamics-C3
Time Frame: baseline through week 36
Change From Baseline in serum Complement 3 (C3) level
baseline through week 36
Pharmacodynamics-complement classical pathway activity by Wieslab® CP
Time Frame: baseline through week 36
Change From Baseline in serum Complement Classical Pathway Activity
baseline through week 36
Pharmacodynamics-complement alternative pathway activity by Wieslab® AP
Time Frame: baseline through week 36
Change From Baseline in Serum Complement Alternative Pathway Activity
baseline through week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Sanegene Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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