Can a single injection drug calm the immune attack on kidneys?

NCT ID NCT06786338

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This phase 2 trial tests an experimental drug called SGB-9768 in adults with three related kidney diseases: IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. These conditions occur when the immune system deposits proteins in the kidney's filtering units, causing protein to leak into urine and leading to progressive kidney damage. The study will measure whether SGB-9768 reduces urine protein levels and preserves kidney function over time. Participants receive the drug by injection, and researchers monitor safety and how the body processes it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SGB-9768, an experimental drug given as a subcutaneous injection
What this could lead to
If it works, SGB-9768 could offer a new way to slow kidney damage and delay the need for dialysis or transplant in people with these rare kidney diseases.
What could go wrong
This is an early phase 2 study with only 45 participants, so the drug may not prove effective or safe in larger groups. Possible side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

45 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • General hospital of ningxia medical university

    Yinchuan, China

  • Guizhou Provincial People's Hospital

    Guiyang, China

  • Henan Provincial People's Hospital

    Zhengzhou, China

  • Huashan hospital

    Shanghai, China

  • Northern Jiangsu People's Hospital

    Yangzhou, China

  • Peking University First Hospital

    Beijing, China

  • Peking University People's Hospital

    Beijing, China

  • Sichuan Provincial People's Hospital

    Chengdu, China

  • The Third Xiangya Hospital of Central South University

    Changsha, China

  • The affiliated hospital of Guizhou medical university

    Guiyang, China

  • The first affiliated hospital, Zhejiang university school of medicine

    Hangzhou, China

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