Actively Recruiting
A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
Led by Ruijin Hospital · Updated on 2025-01-01
118
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of telitacicept in treating patients with primary IgA nephropathy who are at high risk of disease progression. IgA nephropathy is a kidney condition caused by abnormal IgA deposits, leading to diverse symptoms and uncertain causes. This study is a multicenter, randomized, controlled clinical trial aiming to build on earlier findings that telitacicept may reduce protein in the urine and slow disease progression. Participants will be randomly assigned to one of two groups: one group will receive telitacicept 240 mg once a week combined with a stable dose of angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin II receptor blockers (ARB) for 40 weeks. The other group will receive glucocorticoids (prednisone or prednisolone starting at 0.5 mg/kg, up to 40 mg daily, with gradual dose reduction after 8 weeks) together with ACEI/ARB for 28 to 40 weeks. Both groups continue their ACEI/ARB treatment during the study. During the study, participants will have their 24-hour urine protein levels measured from the start until week 40, along with other kidney function tests such as estimated glomerular filtration rate (eGFR) and urine protein creatinine ratio (PCR). Researchers will also monitor safety and record any changes in kidney function or disease progression. The study will last up to 40 weeks, with follow-up to assess the time until any serious kidney-related events occur.
CONDITIONS
Brief 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 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
- Stable treatment with ACEI/ARB for at least 12 weeks before randomization
- Use of SGLT2 inhibitors, MRA, hydroxychloroquine, and similar treatments unchanged
- Voluntary participation with signed informed consent
You will not qualify if you...
- Abnormal laboratory test results as specified 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 such as rituximab within the past 6 months
- Active infections including tuberculosis, hepatitis, herpes zoster, HIV, or positive hepatitis B markers with active virus
- COVID-19 infection within 2 weeks before randomization
- Live vaccination within 4 weeks before randomization
- History of cancer within the past 5 years
- Uncontrolled high blood pressure (systolic >140 mmHg or diastolic >90 mmHg)
- Poorly controlled diabetes (hemoglobin A1c >8%)
- Pregnant or breastfeeding women
- Participation in other clinical trials currently
- Planned surgery, chemotherapy, radiotherapy, or other treatments during the study
- Other conditions deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 weeks
Participants receive either telitacicept once a week combined with ACEI/ARB, or glucocorticoids combined with ACEI/ARB, to treat IgA nephropathy.
Weekly visits for up to 40 weeks
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China, 200025
Actively Recruiting
Research Team
J
Jingyuan Xie
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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