Efficacy and Safety of Telitacicept in IgAN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRuijin Hospital
About this trial
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients with abnormal laboratory indicators (see study protocol for details).
Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
Use of biological agents within 6 months (rituximab, etc.).
Trial design
Treatments tested in this trial
- Telitacicept 240mg
- Glucocorticoid
Treatment groups
118 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ruijin Hospital
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
RenJi Hospital
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Shanghai 6th People's Hospital
Collaborator
Shanghai Longhua Hospital
Collaborator
Huashan Hospital
Collaborator
Shanghai Changzheng Hospital
Collaborator
Wannan Medical College Yijishan Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Collaborator
Source ClinicalTrials.gov