Immunoglobulin A nephropath,IgAN
Conditions
Interventions
Test group:Cizutamig
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years of age at the time of signing the informed consent form (ICF); 2. 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; 3. Angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker inhibitor (ARBi) started >=12 weeks before Screening unless documented intolerance. Patients must be on maximum or maximally tolerated dose (per investigator discretion) >=4 weeks prior to Screening. 4. A patient who is undergoing treatment with a SGLT2 inhibitor, endothelin A receptor antagonist (ETA), and/or hydroxychloroquine must be on a stable dose for >=12 weeks prior to Screening and agree not to start or modify the dose of any of these medications while on study; 5. At least 3 months before screening, patients have a poor response (defined as lack of clinical efficacy or intolerance) to one or more of the following treatments as judged by the investigator: ACEi/ARBi, SGLT2i, ETAs, glucocorticoids or immunosuppressive therapy (such as mycophenolate sodium, cyclophosphamide, etc.), or new marketed drugs such as tetaceptep and budesonide enteric-coated capsules; 6. eGFR determined by Chronic Kidney Disease Epidemiology Collaboration equation >30 mL/min/1.73m^2;
Exclusion criteria
Exclusion criteria: 1.Inadequate clinical laboratory parameters at Screening: a. Peripheral B cells =2.0 × ULN ii. Total bilirubin level and alkaline phosphatase > 2 × ULN (or total bilirubin >2.5 × ULN for patients with Gilbert’s syndrome); 2.Patients will be excluded if they are known to have any of the following: a. Any known human immunodeficiency virus (HIV) infection or positive HIV 1 or 2 at Screening b. Positive hepatitis B surface antigen. Patients with positive hepatitis B core antibody must be tested for hepatitis B virus (HBV)-DNA to determine their status; if HBV-DNA is positive, patients should be excluded; if HBV-DNA is negative, the patient may participate in the study. c. Patients with positive hepatitis C virus (HCV) antibody must be tested for HCV ribonucleic acid (RNA); if HCV RNA is also positive, patients should be excluded; if HCV RNA is negative, the patient may participate in the study d. Active tuberculosis (TB) or lack of documentation of completion of treatment for active TB. If the TB test (QuantiFERON® Gold Test or T-SPOT) is positive, patients may have a chest X-ray to rule out latent or active TB if required by local guidelines/standard of care. If the test result is positive and a chest X-ray is negative for active TB, the patient will be allowed to enroll with documentation of completed treatment for active TB or latent TB. ? If the test result is indeterminant, the site should repeat the test. ? A positive test result or 2 successive indeterminant results should be considered as a positive result. ? An indeterminant test result followed by a negative test result should be considered as a negative test result. Patients with latent TB ? With documented completion of anti-TB therapy prior to study participation may enroll in the study. ? Without documented treatment, patients will be considered a screen failure.e. Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza, or respiratory syncytial virus defined by positive screening test. The patient may be enrolled if either asymptomatic, or afebrile off antipyretics and improving symptoms, for at least 1 week prior to first dose of cizutamig. f. Patient has symptoms and/or signs of confirmed or suspected infection, or fever of 38°C or above, or receiving antimicrobials 1 week prior to first dose of cizutamig. g. Has had any of the following types of infection any time between 3 months prior to Screening and first dose of cizutamig: i. Serious (requiring hospitalization or systemic use of antimicrobials for >= 2 weeks) ii. Opportunistic (including but not limited to pneumocystis jirovecii, cytomegalovirus, toxoplasmosis, histoplasmosis, herpes zoster, as defined in Winthrop et al 2015) iii. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over. iv. Recurring (including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis) Note: Patients with recurrent nonserious infections (eg, urinary tract infection) may be enrolled at the discretion of the investigator if it does not place patients at an increased risk of complications. 3.Receipt of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the PK of cizutamig in patients with IgA nephropathy; | — |
Countries
China
Contacts
Public ContactJicheng Lv
Peking University First Hospital
Outcome results
None listed