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/AClinical Study ID
NCT05596708
SZNK
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Voluntarily sign the informed consent form.
- IgA nephropathy was confirmed by pathological biopsy.
- Age range: ≥ 18 years old, ≤ 70 years old, male or female.
- 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.
- Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) > 35mL/min/1.73 m2.
- 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:
- Abnormal laboratory indicators of participants need to be excluded.
- Secondary IgA nephropathy need to be excluded.
- Specific pathologic or clinical renal disease types, and IgA nephropathy that mayrequire hormone therapy.
- Patients who have experienced any of the following cardiovascular and cerebrovascularevents within the 12 weeks prior to screening.
- Use of systemic corticosteroids within 3 months prior to randomization (except local,nasal inhalation, etc.)
- Immunosuppressants were used within 3 months prior to randomization.
- Patients requiring hospitalization for active infection or intravenous anti-infectivetherapy within 3 months prior to randomization.
- Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
- Herpes zoster HIV antibody positive or HCV antibody positive during the screeningperiod.
- Those who currently have active hepatitis or have severe liver disease and medicalhistory.
- Patients with malignant tumors.
- Pregnant and lactating women, and men or women with planned children during the trialperiod.
- Those who could not avoid the use of nephrotoxic drugs during the trial.
- Allergic to human biological products.
- 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).
- 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
ChinaSite Not Available
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