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B cell-targeted biologics treatment for immune kidney diseases: an observational study

B cell-targeted biologics treatment for immune kidney diseases: an observational study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065889
Enrollment
Unknown
Registered
2022-11-17
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Immune Kidney Diseases

Interventions

Case series:None

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. LN (1) Fulfilling American College of Rheumatology (ACR) or the Systemic Lupus International Collaborating Clinics criteria for classification of SLE; (2) Using B cell-targeted biologics: Rituximab, Belimumab and Telitacicept; (3) Signed Informed consent file. 2. MN (1) Diagnosed by pathological biopsy or positive anti-PLA2R antibody test; (2) Using B cell-targeted biologics: Rituximab, Belimumab and Telitacicept; (3) Signed Informed consent file.

Exclusion criteria

Exclusion criteria: 1. LN (1) Predicted survival of less than 3 months and critically ill patients; (2) Acute phase of various diseases; (3) III or IV heart failure; (4) Viral infections (HIV, specific dermatitis and other diseases that may cause elevated immunoglobulin). 2. MN (1) Predicted survival of less than 3 months and critically ill patients; (2) Active infection; (3) Secondary causes of IMN (hepatitis, SLE, drugs, cancer); (4) III or IV heart failure.

Design outcomes

Primary

MeasureTime frame
B/T lymphocyte subsets;Immunoglobulin subtype;BLys;PLA2R1-Ab, THSD7A-Ab;Single cell sequencing;Kidney tissue biopsy;creatinine;Urea nitrogen;24h Urine protein;

Secondary

MeasureTime frame
Urine eosinophils;NK cell subsets;C3/C4;PLA2R1 epitope spread;cytokines, chemokines;Antinuclear antibody spectrum;Autoantibody spectrum;Blood routine test;Blood biochemistry test;Urine routine test;Color ultrasound of kidney;Extracellular protein differentially expressed gene EP-DEG;CD6/ALCAM;Routine detection of feces;immunoelectrophoresis;coagulation function;Vasculitis screening test;

Countries

China

Contacts

Public ContactXiangmei Chen

Chinese PLA General Hospital

xmchen301@126.com+86 10 66935462

Outcome results

None listed

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