A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 18-70 years old, male or female
• Primary IgA nephropathy confirmed by renal biopsy.
• Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
• eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
• Received treatment with ACEI/ARB for 12 weeks before randomization, and the drug dose (within the maximum tolerated range) was stable within 4 weeks before randomization.
• Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
• Voluntarily participated in this study and signed the informed consent form.
Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jingyuan Xie
nephroxie@163.com
+86-64370045
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 118
Treatments
Experimental: Telitacicept+ACEI/ARB
Active_comparator: Glucocorticoids+ACEI/ARB
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Sichuan Provincial People's Hospital, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital, Wannan Medical College Yijishan Hospital, Huashan Hospital, Shanghai Longhua Hospital, Renmin Hospital of Wuhan University, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Leads: Ruijin Hospital