Study of Telitacicept in Patients With Refractory IgA Nephropathy

Last updated: February 22, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Kidney Disease

Nephropathy

Nephritis

Treatment

N/A

Clinical Study ID

NCT05596708
SZNK
  • Ages 18-70
  • All Genders

Study Summary

The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.

The main questions it aims to answer are:

  • To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy.

  • To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy.

Participants will be subcutaneously injected with 240mg of Telitacicept once per week.

Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.

Eligibility Criteria

Inclusion

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 shouldmeet 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) > 35mL/min/1.73 m2.
  6. Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeksprior to randomization, and the dose of ACE inhibitors/ARBs (within the maximumtolerated range) was stable for 4 weeks prior to randomization.

Exclusion

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 mayrequire hormone therapy.
  4. Patients who have experienced any of the following cardiovascular and cerebrovascularevents 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-infectivetherapy 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 screeningperiod.
  10. Those who currently have active hepatitis or have severe liver disease and medicalhistory.
  11. Patients with malignant tumors.
  12. Pregnant and lactating women, and men or women with planned children during the trialperiod.
  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 torandomization or within 5 times the half-life of the experimental drug (whichever islonger).
  16. Patients deemed ineligible for the trial by the investigator.

Study Design

Total Participants: 40
Study Start date:
March 01, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

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