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IgA Nephropathy (IgAN)Phase 2NCT06786338

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

A Phase 2 study testing SGB-9768 in people with IgA Nephropathy (IgAN) and C3 Glomerulopathy, run by Suzhou Sanegene Bio Inc. at 11 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy (IgAN), C3 Glomerulopathy, IC-MPGN
What is being tested?
SGB-9768
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
11 sitesChina
Study dates
6 Jun 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • The Third Xiangya Hospital of Central South University

    Changsha

  • Sichuan Provincial People's Hospital

    Chengdu

  • Guizhou Provincial People's Hospital

    Guiyang

  • The affiliated hospital of Guizhou medical university

    Guiyang

  • The first affiliated hospital, Zhejiang university school of medicine

    Hangzhou

  • Huashan hospital

    Shanghai

  • Northern Jiangsu People's Hospital

    Yangzhou

  • General hospital of ningxia medical university

    Yinchuan

  • Henan Provincial People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
SGB-9768
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGB-9768Drug

    SGB-9768 for subcutaneous (SC) injection

Study groups in NCT06786338
Study groupRoleWhat they receive
IgAN-1Experimental2 doses of SGB-9768 by subcutaneous (sc) injection
Receives: Drug: SGB-9768
IgAN-2Experimental2 doses of SGB-9768 by subcutaneous (sc) injection
Receives: Drug: SGB-9768
C3G/IC-MPGNExperimental2 doses of SGB-9768 by subcutaneous (sc) injection
Receives: Drug: SGB-9768

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change from baseline in urine protein-creatinine ratio (UPCR)

    Measured: 24 weeks

Secondary outcomes (10)

  1. change from baseline in UACR and 24h-urine protein

    Measured: 24 weeks

  2. change from baseline in estimated glomerular filtration rate (eGFR)

    Measured: 36 weeks

  3. Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

    Measured: from erollment through week 36

  4. Pharmacokinetics-Cmax

    Maximum Observed Plasma Concentration (Cmax)

    Measured: 24 hours

  5. Pharmacokinetics-Tmax

    Time at which the maximum plasma concentration (Cmax) occurs

    Measured: 24 hours

  6. Pharmacokinetics-AUClast

    Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration

    Measured: 24 hours

  7. Pharmacokinetics-t1/2

    Terminal Elimination Half-Life (t1/2)

    Measured: 24 hours

  8. Pharmacodynamics-C3

    Change From Baseline in serum Complement 3 (C3) level

    Measured: baseline through week 36

  9. Pharmacodynamics-complement classical pathway activity by Wieslab® CP

    Change From Baseline in serum Complement Classical Pathway Activity

    Measured: baseline through week 36

  10. Pharmacodynamics-complement alternative pathway activity by Wieslab® AP

    Change From Baseline in Serum Complement Alternative Pathway Activity

    Measured: baseline through week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start6 Jun 2025
  3. Primary completion29 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06786338
Sponsor's protocol ID
SGB-9768-003
Status last verified
Sep 2026
First submitted
10 Jan 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SGB-9768 in people with IgA Nephropathy (IgAN) and C3 Glomerulopathy, run by Suzhou Sanegene Bio Inc. at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline in urine protein-creatinine ratio (UPCR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06786338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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