Study of Telitacicept in Patients With Refractory IgA Nephropathy

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Telitacicept for adults who have a condition known as refractory IgA nephropathy. This condition means that the kidneys are not functioning properly despite previous treatments. The main goals of the trial are to find out how well Telitacicept works and whether it is safe to use. Participants in the study will receive an injection of Telitacicept once a week for several months.

To be eligible for the trial, participants must be between 18 and 70 years old and have been diagnosed with IgA nephropathy through a kidney biopsy. They should also have high levels of protein in their urine after trying standard treatments for at least three months. It's important to note that some individuals, such as those with certain other health conditions or those who have recently used specific medications, may not be eligible to participate. If you or someone you know is interested in learning more about this study, it could be an important opportunity to explore a new treatment option for kidney health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign the informed consent form.
• • 2. IgA nephropathy was confirmed by pathological biopsy.
• • 3. Age range: ≥ 18 years old, ≤ 70 years old, male or female.
• • 4. During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
• • 5. Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) \> 35 mL/min/1.73 m2.
• • 6. Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeks prior to randomization, and the dose of ACE inhibitors/ARBs (within the maximum tolerated range) was stable for 4 weeks prior to randomization.
• Exclusion Criteria:
• • 1. Abnormal laboratory indicators of participants need to be excluded.
• • 2. Secondary IgA nephropathy need to be excluded.
• • 3. Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
• • 4. Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
• • 5. Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
• • 6. Immunosuppressants were used within 3 months prior to randomization.
• • 7. Patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization.
• • 8. Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
• • 9. Herpes zoster HIV antibody positive or HCV antibody positive during the screening period.
• • 10. Those who currently have active hepatitis or have severe liver disease and medical history.
• • 11. Patients with malignant tumors.
• • 12. Pregnant and lactating women, and men or women with planned children during the trial period.
• • 13. Those who could not avoid the use of nephrotoxic drugs during the trial.
• • 14. Allergic to human biological products.
• • 15. Patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer).
• • 16. Patients deemed ineligible for the trial by the investigator.