Evaluation of the therapeutic effect of multi-target therapy on patients with high risk of progression IgA nephropathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400092168

Enrollment

Unknown

Registered

2024-11-12

Start date

2024-12-23

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high risk of progression IgA nephropathy

Interventions

Multi-target therapy group:None

Traditional treatment:None

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 65 years; 2.Renal biopsy confirmed primary IgAN; 3.24-hour urine protein = 1g/24h after 3 months of ACEI/ARB and glucocorticoid treatment; 4.eGFR>45mL/min /1.73m2; 5.Written informed consent provided by the patient or a person with decisional responsibility

Exclusion criteria

Exclusion criteria: 1.Secondary causes of IgA nephropathy, such as IgA vasculitis, viruses (HIV, hepatitis), inflammatory bowel disease, autoimmune diseases, cirrhosis, and other infectious factors; 2.Usage of biologics such as CD20 monoclonal antibody and belimumab for treatment in the past 6 months; 3.Known to be allergic to the investigational drug; 4.Pregnant or recently pregnant women, breastfeeding women; 5.Malignant tumor patients; 6.Patients who underwent surgical treatment within 4 weeks prior to the start of the study; 7.Participants currently participating in clinical studies of other drugs; In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical trial

Design outcomes

Primary

Measure	Time frame
Changes of 24-hour urinary protein quantification relative to baseline at week 12;	—

Secondary

Measure	Time frame
Proportion of patients with 24-hour urinary protein quantification<1g/24h at week 12;The proportion of patients whose hormone dosage decreased by = 50% at 12 weeks;Percentage decrease in hormone levels compared to baseline at each visit time point; Cumulative dose of hormone use;Estimation of changes in glomerular filtration rate (eGFR) relative to baseline at each visit time point;Changes in serum creatinine levels relative to baseline at each visit time point;Changes in urinary protein/creatinine ratio (UPCR) relative to baseline at each visit time point;Changes in immunological indicators (IgA, IgG, IgM) relative to baseline at each visit time point;Incidence of adverse events (AEs) and serious adverse events (SAEs) within 12 weeks;	—

Measure

Time frame

Proportion of patients with 24-hour urinary protein quantification<1g/24h at week 12;The proportion of patients whose hormone dosage decreased by = 50% at 12 weeks;Percentage decrease in hormone levels compared to baseline at each visit time point; Cumulative dose of hormone use;Estimation of changes in glomerular filtration rate (eGFR) relative to baseline at each visit time point;Changes in serum creatinine levels relative to baseline at each visit time point;Changes in urinary protein/creatinine ratio (UPCR) relative to baseline at each visit time point;Changes in immunological indicators (IgA, IgG, IgM) relative to baseline at each visit time point;Incidence of adverse events (AEs) and serious adverse events (SAEs) within 12 weeks;

—

Countries

China

Contacts

Public ContactZhang Ling

West China Hospital of Sichuan University

zhangling_crrt@163.com+86 189 8060 1985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026