Evaluating telitacicept for treating IgA nephropathy

A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy

This study is testing if a new treatment called telitacicept can help people with IgA nephropathy who are at high risk of their condition getting worse.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: rituximab, chemotherapy, cyclophosphamide
• Locations: 1 site (Shanghai)
• Trial ID: NCT06654596 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with confirmed primary IgA nephropathy and specific proteinuria levels.

Not a fit: Patients with secondary IgA nephropathy or those who have recently used systemic glucocorticoids or immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with IgA nephropathy by reducing disease progression and associated complications.

How similar studies have performed: Previous studies have shown promising results with telitacicept in treating IgA nephropathy, indicating a potential for success in this approach.

Eligibility criteria

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 this trial is running

Shanghai

• Ruijin Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jingyuan Xie

Conditions IgA Nephropathy; Kidney Diseases; Telitacicept; Glucocorticoid