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

Launched by SUZHOU SANEGENE BIO INC. · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SGB-9768 for patients with certain kidney diseases, specifically IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. The goal is to find out how well and safely this treatment works in patients who have been diagnosed with these conditions, which can affect the kidneys' ability to filter waste from the blood.

To be eligible for the trial, participants must be at least 18 years old, weigh at least 40 kg, and have a confirmed diagnosis of one of the kidney diseases mentioned. They should also have specific levels of protein in their urine and a certain level of kidney function. Additionally, participants need to be on stable doses of certain blood pressure medications for at least 12 weeks before joining the study. This trial is currently not recruiting participants, so it's not yet open for enrollment. If someone qualifies and decides to participate, they can expect close monitoring during the study to assess how they respond to the treatment and any potential side effects.

Gender

ALL

Eligibility criteria

• 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)