Tests telitacicept in adults with IgA nephropathy at high risk of kidney decline
Tests telitacicept with steroids in adults with IgA nephropathy at high risk of progression.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Telitacicept in IgAN
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06654596, who can take part
Where in China
- Ruijin hospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT06654596
- Record updated
- 1 January 2025
- Original description
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.Read full original descriptionShow less
A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
Inclusion: 18-70 years old, male or female; Primary IgA nephropathy confirmed by renal biopsy; Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g; eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula; 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; Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged; Voluntarily participated in this study and signed the informed consent form.
Exclusion: COVID-19 infection within 2 weeks before randomization; Live vaccine within 4 weeks before randomization; Surgery, chemotherapy, radiotherapy and other treatments are planned during the study; 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; History of malignant tumor within five years; Uncontrolled hypertension (systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg); Patients with abnormal laboratory indicators (see study protocol for details); Poorly controlled diabetes (glycosylated hemoglobin>8%); Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc; Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.); Use of biological agents within 6 months (rituximab, etc.); Pregnant women and breastfeeding women; Participating in other clinical trials at the same time; Other reasons judged by researchers as unsuitable for inclusion in the study.