Primary IgA nephropathy
Conditions
Interventions
Prior Treatment Group:None
Ongoing Treatment Group:None
Planned Treatment Group:None
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Prior Treatment Group: Age >= 18 years; Pathologically diagnosed with immune-mediated kidney disease, including but not limited to primary IgA nephropathy, primary membranous nephropathy, systemic lupus erythematosus nephritis, etc.; Previously received treatment with telitacicept, with a total treatment duration of >= 24 weeks. 2.Ongoing Treatment Group: Age >= 18 years; Pathologically diagnosed with immune-mediated kidney disease, including but not limited to primary IgA nephropathy, primary membranous nephropathy, systemic lupus erythematosus nephritis, etc.; Currently receiving telitacicept treatment at the time of enrollment, with an expected total treatment duration of >= 24 weeks; Able and willing to sign the informed consent form for data collection in the ongoing treatment group. 3.Planned Treatment Group: Age >= 18 years; Pathologically diagnosed with immune-mediated kidney disease, including but not limited to primary IgA nephropathy, primary membranous nephropathy, systemic lupus erythematosus nephritis, etc.; Have never received telitacicept treatment prior to enrollment, are assessed by the clinician as meeting the indication for medication, and are planned to initiate telitacicept treatment after enrollment with an expected total treatment duration of >= 24 weeks; Able and willing to sign the informed consent form for data collection in the planned treatment group.
Exclusion criteria
Exclusion criteria: 1.Prior Treatment Group: Renal pathology or clinical diagnosis indicates the presence of other non-immune-mediated kidney diseases; Interruption of telitacicept treatment for more than 4 weeks; Patients whose medical records are insufficient to collect baseline and endpoint event data; Patients whose medical records indicate concurrent participation in other clinical trials. 2.Ongoing Treatment Group: Renal pathology or clinical diagnosis indicates the presence of other non-immune-mediated kidney diseases; Interruption of telitacicept treatment for more than 4 weeks in the retrospective part; Patients whose medical records are insufficient to collect baseline and key visit data in the retrospective part; Presence of active or uncontrolled infections in the prospective part; Concurrent participation in other interventional clinical trials; Pregnancy or breastfeeding at the time of enrollment; Male or female participants with a plan for childbirth within 6 months after the study period who do not agree to take effective contraceptive measures. 3.Planned Treatment Group: Renal pathology or clinical diagnosis indicates the presence of other non-immune-mediated kidney diseases; Patients with active or uncontrolled infections during the screening period; Patients concurrently participating in other clinical trials; Women who are pregnant or breastfeeding during the screening period, or male or female participants with a plan for childbirth within 6 months after the study and who do not agree to take effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission Rate of Proteinuria at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Serum Albumin from Baseline;Overall Remission Rate at Week 24 by Pathological Type Subgroup;Change in 24-hour Proteinuria or UPCR from Baseline;Change in eGFR from Baseline at Week 24;Change in SLEDAI-2K Score in LN from Baseline at Week 24;Cumulative Incidence of Kidney Composite Endpoint Events;Complete Immunological Remission Rate in MN at Week 24;Remission Rate of Hematuria in IgAN at Week 24;Overall Remission Rate at Week 24;Complete Remission Rate at Week 24 by Pathological Type Subgroup; | — |
Countries
China
Contacts
Public ContactLin Hongli
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed