A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516380-81-00

Acronym

VT-001-0051

Enrollment

Registered

2025-01-31

Start date

2025-02-28

Completion date

Unknown

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of IgAN

Brief summary

Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events

Detailed description

The effect of atacicept on the following: *Changes in proteinuria based on UPCR and UACR as determined by spot urine. *Changes in estimated glomerular filtration rate (eGFR) based on serum creatinine and cystatin C, respectively. *Hematuria level based on blood on urine dipstick. *Changes in serum Gd-IgA1 levels.

Interventions

DRUGAtacicept Autoinjector Combination

DRUGAtacicept

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events	—

Secondary

Measure	Time frame
The effect of atacicept on the following: Changes in proteinuria based on UPCR and UACR as determined by spot urine. Changes in estimated glomerular filtration rate (eGFR) based on serum creatinine and cystatin C, respectively. Hematuria level based on blood on urine dipstick. Changes in serum Gd-IgA1 levels.	—

Countries

Belgium, Czechia, Germany, Greece, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026