A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Sanegene Bio Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SGB-9768
Treatment groups
38 Participants
are divided into 3 treatment groupsLocations
11Peking University First Hospital Beijing China
Peking University People's Hospital Beijing China
The Third Xiangya Hospital of Central South University Changsha China
Sichuan Provincial People's Hospital Chengdu China
Sponsors and collaborators
Suzhou Sanegene Bio Inc.
Lead sponsor
Source ClinicalTrials.gov