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Telitacicept 240mg for Immunoglobulin A Nephropathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Remegen Site #10, Sacramento, CAImmunoglobulin A NephropathyTelitacicept 240mg - Drug
Eligibility
18 - 70
All Sexes
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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

1 of 3

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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

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Mezagitamab
2
VX-147
2
BI 764198

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: Drug
Telitacicept 240mg
Drug
Experimental Group · 1 Intervention: Telitacicept 240mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial 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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