Study Summary
This trial tests a drug for a kidney disease to see if it is safe and effective.
Eligible Conditions
- Immunoglobulin A Nephropathy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
27 weeks
The incidence and severity of adverse events
Week 0
Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR)
Week 0
Changes from baseline in immunological parameters
Immunogenicity endpoints
Pharmacokinetic endpoints
Week 0
Biomaker endpoints serum concentration
Change from baseline in Estimated Glomerular Filtration Rate (eGFR)
Week 24
Change from baseline in 24-hour urine protein at Week 24.
Week 4
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Week 4
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Week 4
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
3 Treatment Groups
Telitacicept 160mg
1 of 3
Telitacicept 240mg
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
30 Total Participants · 3 Treatment Groups
Primary Treatment: Telitacicept 240mg · Has Placebo Group · Phase 2
Telitacicept 160mg
Drug
Experimental Group · 1 Intervention: Telitacicept 160mg · Intervention Types: DrugTelitacicept 240mg
Drug
Experimental Group · 1 Intervention: Telitacicept 240mg · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and eot visit.
Who is running the clinical trial?
RemeGen Co., Ltd.Lead Sponsor
50 Previous Clinical Trials
6,804 Total Patients Enrolled
Eligibility Criteria
Age 18 - 70 · All Participants · 5 Total Inclusion Criteria
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