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

NCT06656962 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-24

No results posted yet for this study

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)

Interventions

DRUG

Telitacicept 160mg

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

DRUG

Prednisone (and methylprednisolone)

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

DRUG

Cyclophosphamide

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

Sponsors & Collaborators

  • Renmin Hospital of Wuhan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2025-12-30
Completion
2026-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656962 on ClinicalTrials.gov