Active — Not RecruitingPhase 2

A Clinical Trial With KJ103 in Anti-GBM Disease

China12 participantsStarted 2024-10-21

Plain-language summary

An open-label, single-arm Phase II study to evaluate the preliminary efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients aged ≥18 years, both sexes.
✓. Diagnosed with anti-GBM disease. Positive anti-GBM antibodies at screening, with or without ANCA antibody positivity.
✓. With or without symptoms of haematuria and proteinuria.
✓. Patients of childbearing potential who do not plan to have children during the study and for 6 months after the end of the study, or who are using effective contraception during sexual intercourse.

Exclusion criteria

✕. Anuria for more than 24 hours prior to the first dose.
✕. Diagnosis of anti-GBM disease more than 14 days prior to first dose.
✕. Moderate to severe pulmonary haemorrhage requiring mechanical ventilation during the screening period, including those occurring within two weeks prior to signing the informed consent form.
✕. Severe renal disease not caused by anti-GBM disease, such as lupus nephritis, which, in the opinion of the investigator, makes them unsuitable for participation in this study.
✕. Pregnant or breastfeeding at the time of screening.
✕. Have a serious underlying medical condition other than anti-GBM disease, such as infection, autoimmune disease, respiratory disease, cardiovascular disease, central nervous system disease, etc., that the investigator deems unsuitable for participation in this trial.

What they're measuring

Renal function

Timeframe: day 90, day 180

Trial details

NCT IDNCT06607016

SponsorShanghai Bao Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Anti-Glomerular Basement Membrane Disease trials