Actively Recruiting
Efficacy and Safety of Telitacicept in IgAN
Led by Ruijin Hospital · Updated on 2025-01-01
118
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
X
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
CONDITIONS
Official Title
Efficacy and Safety of Telitacicept in IgAN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 70 years old, male or female
- Primary IgA nephropathy confirmed by kidney biopsy
- Urine protein level of at least 0.75 g per 24 hours or urine protein creatinine ratio of at least 0.6 g/g
- Estimated glomerular filtration rate (eGFR) of at least 25 ml/min/1.73 m2
- Treated with ACEI or ARB drugs for at least 12 weeks with stable dose for 4 weeks before randomization
- Stable use of other medications such as SGLT2 inhibitors, MRAs, or hydroxychloroquine
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Abnormal laboratory test results as detailed in the study protocol
- Secondary IgA nephropathy caused by other diseases like Henoch-Schonlein purpura, lupus, or cirrhosis
- Use of systemic glucocorticoids or immunosuppressants within the past 3 months
- Use of biological agents like rituximab within the past 6 months
- Active infections including tuberculosis, hepatitis, herpes zoster, HIV, or positive hepatitis B surface antigen
- COVID-19 infection within 2 weeks before randomization
- Receipt of live vaccines within 4 weeks before randomization
- History of cancer within the last 5 years
- Uncontrolled high blood pressure (systolic >140 mmHg or diastolic >90 mmHg)
- Poorly controlled diabetes (HbA1c >8%)
- Pregnant or breastfeeding women
- Participation in other clinical trials simultaneously
- Planned surgery, chemotherapy, or radiotherapy during the study
- Any other condition deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China, 200025
Actively Recruiting
Research Team
J
Jingyuan Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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