Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2024-12-06
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telitacicept+ACEI/ARB
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.
Glucocorticoids+ACEI/ARB
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Primary IgA nephropathy confirmed by renal biopsy.
3. Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
4. eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
5. 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.
6. Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
7. Voluntarily participated in this study and signed the informed consent form.
Exclusion Criteria
2. Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
3. Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
4. Use of biological agents within 6 months (rituximab, etc.).
5. Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpes zoster, HIV, etc. According to the results of the five hepatitis B test: patients with positive HBsAg should be excluded; patients with negative HBsAg but positive HBcAb, regardless of whether HBsAb is positive or negative, need to test HBV-DNA to determine their situation: if HBV-DNA is positive, the patient needs to be excluded; if HBV-DNA is negative, the patient can participate in the trial.
6. COVID-19 infection within 2 weeks before randomization.
7. Live vaccine within 4 weeks before randomization.
8. History of malignant tumor within five years.
9. Uncontrolled hypertension (systolic blood pressure\>140mmHg or diastolic blood pressure\>90mmHg).
10. Poorly controlled diabetes (glycosylated hemoglobin\>8%).
11. Pregnant women and breastfeeding women.
12. Participating in other clinical trials at the same time.
13. Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.
14. Other reasons judged by researchers as unsuitable for inclusion in the study.
18 Years
70 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
RenJi Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
Renmin Hospital of Wuhan University
OTHER
Shanghai 6th People's Hospital
OTHER
Shanghai Longhua Hospital
UNKNOWN
Huashan Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
Wannan Medical College Yijishan Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
OTHER_GOV
Ruijin Hospital
OTHER
Responsible Party
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Xie Jingyuan, MD
Chief physician
Locations
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Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TETA-IgA
Identifier Type: -
Identifier Source: org_study_id
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