Trials Sponsors Conditions Drugs Pricing

Conditions

Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)

Keywords

ANCA-associated nephritisANCAAntineutrophil cytoplasmic antibody (ANCA)-associated vasculitisAAGN

Outcome Measures

Primary Outcomes (2)

The complete remission rate of AAGN
The complete remission of AAGN is defined as no manifestations of glomerulonephritis (the renal item score of Birmingham vasculitis activity score \[BVAS\] is 0); the renal item score of BVAS can range from 0 to 58.
24 weeks
The partial remission rate of AAGN
The partial remission refers to no active urinary sediment, stable or decreased Scr level, or a reduction of more than 50% in the renal item score of Birmingham vasculitis activity score \[BVAS\]; the renal item score of BVAS can range from 0 to 58.
24 weeks

Secondary Outcomes (3)

The complete remission rate of ANCA
24 weeks
The partial remission rate of ANCA
24 weeks
Safety and tolerability of patients, occurrence and recurrence of adverse events during the trial
24 weeks

Other Outcomes (3)

Changes in renal function compared with baseline during follow-up
48 weeks
Occurrence of adverse events during follow-up
48 weeks
Recurrence of patients during follow-up.
48 weeks

Study Arms (1)

The Telitacicept treatment group

EXPERIMENTAL

Drug: Telitacicept 160mgDrug: Prednisone (and methylprednisolone)Drug: Cyclophosphamide

Interventions

Telitacicept 160mgDrug

Telitacicept for Injection combined with standard therapy (Prednisone and Cyclophosphamide) for the treatment of ANCA-associated nephritis (AAGN).

Also known as: Prednisone, Cyclophosphamide

The Telitacicept treatment group

Prednisone (and methylprednisolone)Drug

Methylprednisone shock therapy (500mg, 3 times), followed by Prednisone (1 mg·kg·d and a pre-determined tapering guideline \[PEXIVAS regimen\]).

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years and ≤ 75 years, both male and female are included.
Clinically diagnosed as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the definition of the 2012 Chapel Hill Consensus Conference (CHCC).

Sponsors & Collaborators

Renmin Hospital of Wuhan University
Otherlead

Study Sites (1)

Renmin hospital of Wuhan University

Wuhan, Hubei, China

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

telitaciceptPrednisoneCyclophosphamideMethylprednisolone

Condition Hierarchy (Ancestors)

Systemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director, Professor

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 24, 2024

Study Start

October 10, 2024

Actual (reported)

You may not qualify if:

Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.).
Secondary vasculitis (such as systemic lupus erythematosus, Henoch-Schönlein purpura, drugs, tumors, infections, primary immunodeficiency, etc.).
Patients with primary kidney diseases (such as IgA nephropathy, membranous nephropathy and anti-glomerular basement membrane nephritis, etc.).
Major or uncontrolled diseases unrelated to AAV.
Rapidly progressive glomerulonephritis with rapid decline in renal function: estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m² before the first administration, or already receiving continuous dialysis treatment.
Patients with central nervous system diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
Other multisystem autoimmune diseases including systemic lupus erythematosus, IgA, rheumatoid vasculitis, anti-glomerular basement membrane disease, cryoglobulinemic vasculitis, etc.
Active hepatitis or a history of severe liver disease or liver lesions (HBsAg positive, or HBcAb positive and HBV-DNA positive), active pulmonary tuberculosis.
Immunodeficiency, uncontrolled severe infection.
Abnormal laboratory indicators that need to exclude subjects include but are not limited to the following indicators: total bilirubin ≥ 3 times the upper limit of normal, alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal, aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal, white blood cell (WBC) \< 2.5×109/L, hemoglobin (Hb) \< 85 g/L, platelet count (PLT) \< 50×109/L.
Received any of the following treatments within 364 days before day 0: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 drugs, anti-CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\], BLyS receptor fusion protein \[BR3\], TACI-Fc); b) abatacept; c) experimental biological products.
Patients who have undergone kidney transplantation or other organ transplantation.
Received intravenous immunoglobulin or plasma exchange within 4 weeks before the first administration.
Pregnant women, lactating women and men or women with plans for childbearing during the trial.
Participated in other new drug clinical trials within 3 months before the first administration.
+5 more criteria

The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Other Outcomes (3)

Study Arms (1)

The Telitacicept treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Other Outcomes (3)

Study Arms (1)

The Telitacicept treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations