Tests cizutamig in adults with immunoglobulin A nephropathy
Tests cizutamig for safety and early effects in adults with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07135219, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT07135219
- Record updated
- 22 August 2025
- Original description
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with IgAN.Read full original descriptionShow less
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Immunoglobulin A Nephropathy
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with IgAN.
Inclusion: 18 to 75 years of age at the time of signing the informed consent form (ICF); Biopsy-confirmed IgAN as specified in the protocol; 24-hour urine protein excretion ≥1.0 g/day or 24-hour urine protein to creatinine ratio (uPCR) ≥0.75 g/g ; Inadequate response to ≥1 of the therapies defined in the protocol; eGFR >30 mL/min/1.73m2.
Exclusion: Receipt of or inability to discontinue any of the following excluded therapies as specified in the protocol; Receipt of live vaccine within 4 weeks prior to Screening; Presence of any concomitant autoimmune disease ; Presence of 1 or more significant concurrent medical conditions per investigator judgment; Tonsillectomy within 24 weeks prior to Screening; Secondary IgAN (eg, chronic liver disease, celiac disease, HIV); History of IgA vasculitis; History of progressive multifocal leukoencephalopathy; History of primary immunodeficiency or a hereditary deficiency of the complement system; Central nervous system (CNS) disease ; Diagnosis or history of malignant disease within 5 years prior to Screening; Inadequate clinical laboratory parameters at Screening; Rapidly progressing glomerulonephritis with eGFR reduction ≥50% within 12 weeks of Screening; MEST-C score of T2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of >50% tubular atrophy/interstitial fibrosis is exclusionary.