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

NCT06656962 | Active Not Recruiting Phase 1

• 1 other identifier: RCTAIIRANCA001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, open-label exploratory clinical study conducted in subjects with ANCA-associated nephritis (AAGN), aiming to evaluate the efficacy and safety of Telitacicept in the treatment of AAGN.

Conditions

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

Keywords

ANCA-associated nephritis; ANCA; Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis; AAGN

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 160mg; Drug: Prednisone (and methylprednisolone); Drug: Cyclophosphamide

Interventions

Telitacicept 160mg DRUG

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 \[PEXIVAS regimen\]).

The Telitacicept treatment group

Cyclophosphamide DRUG

Cyclophosphamide, intravenous injection, once every 2 to 3 weeks, 0.75 g/m² each time, the maximum cumulative dose of 8g

The Telitacicept treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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).
• Positive serological detection of autoantibodies, defined as follows: positive anti-proteinase 3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) (previous or screening test results).
• Renal involvement at screening, defined as at least one of the following: (1) At least one renal item in the Birmingham Vasculitis Activity Score (BVAS) version 3.0; (2) According to the pathological classification criteria formulated by the European Vasculitis Society (EUVAS) in 2003, there is active, biopsy-confirmed ANCA-associated nephritis (biopsy must be performed within 1 year before the screening visit or during the screening period); (3) Microscopic examination of urine shows red blood cell casts.
• Voluntarily participate in this clinical trial and sign the informed consent form.

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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin hospital of Wuhan University

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

telitacicept; Prednisone; Cyclophosphamide; Methylprednisolone

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Prednisolone; Pregnadienetriols

Study Design

• Study Type: interventional
• Phase: phase 1
• 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
• Primary Completion: December 30, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

CN (1)