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Tests treatment safety and results for IgA Nephropathy (IgAN)
Official title Efficacy and Safety of Telitacicept in IgAN
ClinicalTrials.gov ID: NCT06654596
What this study is testing
What is Telitacicept 240mg?
Telitacicept 240mg is an investigational medicine, given as an once-weekly, being studied as a potential treatment for iga nephropathy (igan).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- Patients with abnormal laboratory indicators (see study protocol for details).
- 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...
- Use of biological agents within 6 months (rituximab, etc.).
- Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpes zoster, HIV, etc. According to the results of the five hepatitis...
- COVID-19 infection within 2 weeks before randomization.
See the full eligibility criteria
- 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.
- Patients with abnormal laboratory indicators (see study protocol for details).
- 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.).
- 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...
- COVID-19 infection within 2 weeks before randomization.
- Live vaccine within 4 weeks before randomization.
- History of malignant tumor within five years.
- Uncontrolled hypertension (systolic blood pressure\>140mmHg or diastolic blood pressure\>90mmHg).
- Poorly controlled diabetes (glycosylated hemoglobin\>8%).
- Pregnant women and breastfeeding women.
- Participating in other clinical trials at the same time.
- Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.
- Other reasons judged by researchers as unsuitable for inclusion in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.