Clinical trial NCT06786338: A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: IgA Nephropathy (IgAN)
C3 Glomerulopathy
IC-MPGN
Lead sponsor: Suzhou Sanegene Bio Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.

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.

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)

Primary outcomes:
measure: change from baseline in urine protein-creatinine ratio (UPCR)
timeFrame: 24 weeks
Secondary outcomes:
measure: change from baseline in UACR and 24h-urine protein
timeFrame: 24 weeks
measure: change from baseline in estimated glomerular filtration rate (eGFR)
timeFrame: 36 weeks
measure: Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
timeFrame: from erollment through week 36
measure: Pharmacokinetics-Cmax
timeFrame: 24 hours
measure: Pharmacokinetics-Tmax
timeFrame: 24 hours
measure: Pharmacokinetics-AUClast
timeFrame: 24 hours
measure: Pharmacokinetics-t1/2
timeFrame: 24 hours
measure: Pharmacodynamics-C3
timeFrame: baseline through week 36
measure: Pharmacodynamics-complement classical pathway activity by Wieslab® CP
timeFrame: baseline through week 36
measure: Pharmacodynamics-complement alternative pathway activity by Wieslab® AP
timeFrame: baseline through week 36
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
city: Guiyang
country: China
facility: The affiliated hospital of Guizhou medical university
city: Hangzhou
country: China
facility: The first affiliated hospital, Zhejiang university school of medicine
city: Shanghai
country: China
facility: Huashan hospital
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
city: Yinchuan
country: China
facility: General hospital of ningxia medical university
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
References: