FindTrial
Sign In

The effectiveness and safety of protein A immunoadsorption therapy in Immune-related critically ill patients

Prospective Clinical Study of Protein A Immunoadsorption for Immune-related Critical Illness

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029390
Enrollment
Unknown
Registered
2020-01-29
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

Immune-related Critical Illness

Interventions

Group 1:Protein A Immunoadsorption
Group 2:Plasma exchange
Group 3:Immunosuppressive plus Glucocorticoid treatment

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Positive Diagnosis of WG or MPA (according to the consensus of Chapel Hill meeting); (2) Serum ANCA positive: MPO or PR3 positive (indirect immunofluorescence and / or ELISA two methods Detection); (3) Renal Injury: with hematuria and / or proteinuria; or renal pathology showing a few immune segmental necrosis Nephritis and / or crescentic nephritis; (4) Estimated glomerular filtration rate (Cockcroft-Grault formula) <50 mL / min; (5) Other organ damage (such as lung, skin, joints, etc.) accompanied by active vasculitis ; (6) Aged 18 to 70 years; (7) Signed voluntarily informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with malignant tumors; (2) Pregnant or lactating women; (3) Patients with immunodeficiency; (4) Patients with mental disorders, or with poor compliance; (5) Accompanied by severe liver, heart or system diseases ( Aspartate aminotransferase (AST) or alanine Aminotransferase (ALT) is 2.5 times higher than the upper limit of normal.Colic, heart failure, angioplasty, bypass surgery, transient ischemic attack or stroke); (6) Combined with severe infections; (7) Combined with active tuberculosis, hepatitis B or C virus; (8) Human immunodeficiency virus (HIV) seropositivity; (9) Combining other autoimmune diseases (such as systemic lupus erythematosus, allergic purpura, rheumatoid vasculitis,Cryoglobulinemia, anti-glomerular basement membrane disease, etc.); (10) Patients who are allergic to standard treatment drugs or have serious side effects (such as hemorrhagic cystitis, etc.) (11) Live vaccinations in the last month; (12) Patients who have received dialysis in the past month; (13) Large doses of cytotoxic drugs have been used in the past 3 months; (14) Protein A immunoadsorption therapy has been performed in the last 3 months.

Design outcomes

Primary

MeasureTime frame
Serum creatinine;Full immunoglobulin test;—

Countries

China

Contacts

Public ContactFu-you Liu

The Second Xiangya Hospital of Central South University

lfy2061@163.com+86 13808488859

Outcome results

None listed

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