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

ConditionsIgA Nephropathy (IgAN)C3 GlomerulopathyIC-MPGN
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SGB-9768

    Drug

    SGB-9768 for subcutaneous (SC) injection

Treatment groups

38 Participants
are divided into 3 treatment groups
Group A: IgAN-1Experimental treatment 1 intervention
Group B: IgAN-2Experimental treatment 1 intervention
Group C: C3G/IC-MPGNExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 weeks

Secondary outcomes

1

change from baseline in UACR and 24h-urine protein

Time frame
24 weeks
2

change from baseline in estimated glomerular filtration rate (eGFR)

Time frame
36 weeks
3

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

Time frame
from erollment through week 36
4

Pharmacokinetics-Cmax

Maximum Observed Plasma Concentration (Cmax)

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Sanegene Bio Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: