IgA nephropathy
Conditions
Interventions
Telitacicept:subcutaneous injection of Telitacicept
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects are older than 18 and younger than 75 years of age; 2) Subjects have a diagnosis of IgAN confirmed by a source-verified renal biopsy; 3) At screening, subjects must meet a urine protein creatinine ratio (UPCR) of greater than 0.5 and less than 3.5 or 24-hour urine protein of greater than 0.75g and less than 3.5g ; 4) Subject's glomerular filtration rate using the CKD-EPI formula at screening must satisfy an eGFR = 30mL/min/1.73m2. for exploratory cohorts, subjects with an eGFR of 20-30mL/min/1.73m2. 5) Subjects with IgAN have received a stable and maximally tolerated dose of a marketed angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB; according to local standards of care and applicable guidelines) for at least 3 months prior to screening. In addition to ACEIs/ARBs, subjects receiving stable doses of SGLT2 inhibitors for IgAN prior to screening may also be enrolled in the trial. 6) Ability to provide written informed consent prior to the initiation of any trial-specific procedures and who, in the opinion of the Principal Investigator, is capable of complying with all requirements of this trial.
Exclusion criteria
Exclusion criteria: 1) Renal biopsy was T2 or C2 scored by MEST or MEST-C(Oxford classification for IgA nephropathy). If MEST score is not performed, subjects with the presence of tubulointerstitial fibrosis >50% or glomerular crescents >25% should be excluded. 2) Subjects with secondary IgAN (e.g., infection-associated IgAN or IgAN associated with cirrhosis) or anaphylactic purpura (IgA vasculitis). 3) Subjects with comorbid chronic kidney disease other than IgAN. 4) Renal biopsy reveals other pathologic abnormalities (eg, diabetic nephropathy, membranous nephropathy, or lupus nephritis). However, hypertensive vasculopathy is acceptable. 5) Subjects with a history of, or current evidence of, severe and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, hematologic malignancies, or other medical disorders, including psychiatric disorders, cirrhosis of the liver, or persistent malignancies. Subjects with a history of mild skin cancer (excluding melanoma) or surgically treated limited cervical cancer (i.e., carcinoma in situ) may be excluded at the discretion of the investigator. 6) Prior history of severe allergic reactions, including generalized urticaria, angioedema, or anaphylactic reactions. 7) Body mass index 8% at screening. Subjects with unstable diabetes treatment regimens were excluded. A stable diabetes regimen is defined as a regimen with the aid of diet and exercise therapy alone or in combination with any marketed antidiabetic medication in which the dose of oral or non-insulin injectable medication has not changed in the 8 weeks prior to enrollment; or the dose of long-acting insulin or intermediate-acting insulin has not changed by more than 20% in the 8 weeks prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urine protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated glomerular filtration rate; | — |
Countries
China
Contacts
Public ContactYan Yan
The First Affiliated Hospital of Nanchang University
Outcome results
None listed