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SGB-9768 for Primary IgA Nephropathy and Related Conditions

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What is being tested

SGB-9768

Drug
Who is being recruted

Urogenital Diseases+8

+ Autoimmune Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorSuzhou Sanegene Bio Inc.
Study ContactMedical mananger
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on testing a new treatment called SGB-9768 for patients with certain types of kidney diseases, specifically primary IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. These conditions can lead to significant protein loss in the urine and deteriorating kidney function. The goal is to see if SGB-9768 can reduce protein in the urine and help maintain kidney health. Evaluating new treatments is crucial for improving care for these patients, as current options may not be effective for everyone. Participants in this study will receive the treatment SGB-9768, though the method of administration is not specified. Researchers will assess if the treatment effectively reduces protein levels in the urine and helps maintain kidney function. Additionally, the study will monitor the safety of the treatment, and how the body processes and responds to it. Understanding the potential risks and benefits is a key part of determining whether SGB-9768 can be a viable treatment option for these kidney conditions.

Official TitleA 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.
NCT06786338
Principal SponsorSuzhou Sanegene Bio Inc.
Study ContactMedical mananger
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisGlomerulonephritis, IGAImmune System DiseasesKidney DiseasesNephritisUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

7 inclusion criteria required to participate
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
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14 exclusion criteria prevent from participating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
2 doses of SGB-9768 by subcutaneous (sc) injection

Group II

Experimental
2 doses of SGB-9768 by subcutaneous (sc) injection

Group III

Experimental
2 doses of SGB-9768 by subcutaneous (sc) injection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Suspended

Peking University People's Hospital

Beijing, ChinaOpen Peking University People's Hospital in Google Maps
Suspended

Peking University First Hospital

Beijing, China
Suspended

The Third Xiangya Hospital of Central South University

Changsha, China
Suspended

Sichuan Provincial People's Hospital

Chengdu, China
Recruiting soon11 Study Centers