Efficacy and Safety of Telitacicept in IgAN

Summary

A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.

Conditions

• IgA Nephropathy (IgAN)
• Kidney Diseases
• Telitacicept
• Glucocorticoid

Interventions

DRUG

Telitacicept 240mg

Patients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and/or angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks.

DRUG

Glucocorticoid

Patients in glucocorticoid group will be treated with ACEI/ARB and glucocorticoid ( prednisone/prednisolone) 0.5mg/kg (maximum 40mg/d). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Shanghai Longhua Hospital

  collaborator UNKNOWN

• Huashan Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Wannan Medical College Yijishan Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine

  collaborator OTHER_GOV

• Ruijin Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-06

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China

Study Locations