Evaluating telitacicept for treating IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of telitacicept, a recombinant human B lymphocyte stimulator receptor-antibody fusion protein, in patients with primary IgA nephropathy who are at high risk of disease progression. The study will involve a multicenter, randomized, controlled design, building on previous Phase II trial results that indicated telitacicept's potential to reduce proteinuria and slow disease progression. Participants will be closely monitored for both therapeutic effects and safety outcomes throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18-70 years old, male or female
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:

1. Patients with abnormal laboratory indicators (see study protocol for details).
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.

Where it's running

• Ruijin Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jingyuan Xie
• Email: nephroxie@163.com
• Phone: +86-64370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JADE101 in IgA Nephropathy (phase 3, blinded)

  This phase 3 study tests whether JADE101 helps adults with IgA nephropathy more than a placebo.

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• Personalized IgA Nephropathy treatment guided by Gd-IgA1 monitoring

  This study tests whether regularly checking a biomarker called Gd-IgA1 to guide treatment with Nefecon or telitacicept helps people with IgA nephropathy or related nephritis respond better.

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• Long-term safety and effectiveness of HSK39297 tablets in IgA nephropathy patients who completed prior study

  This phase 2 trial tests whether taking HSK39297 once daily for IgA nephropathy is safe over the long term and helps reduce protein in the urine for patients who completed a previous study and meet criteria.

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• Everest001: a medicine for certain kidney diseases to see if it helps adults

  This study tests EVER001 in adults with FSGS, MCD, or IgA nephropathy to see if it can help reduce protein in the urine and improve kidney function.

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• Nefecon as a maintenance therapy to prevent relapse in IgA nephropathy

  This study tests whether continuing Nefecon after initial remission can lower the chance of relapse in adults with IgA nephropathy.

  Recruiting Phase 4 Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT07604311

• CD19/BCMA UCART for B cell–related autoimmune diseases

  This early-stage study tests QT-219CX, a universal allogeneic CAR-T cell therapy that targets CD19 and BCMA, in people with refractory B-cell–related autoimmune diseases to see if it can be given safely and provide early signs of benefit.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07586267

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.