A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN
Key facts
- Where
- Almería, Barcelona, Pamplona, Santiago de Compostela és Sevilla, SpanyolországSee the 6 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Universitario TorrecárdenasAlmería, SpanyolországNo longer taking part
- Hospital Clinic de BarcelonaBarcelona, SpanyolországNo longer taking part
- Hospital del MarBarcelona, SpanyolországNo longer taking part
- Clínica Universidad de navarraPamplona, SpanyolországNo longer taking part
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországNo longer taking part
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vera Therapeutics Inc.
- Trial code
- EU 2025-521519-37-00
- Record updated
- 2026. június 16.
- Original description
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgANRead full original descriptionShow less
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
Inclusion: Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments; Diagnosis of IgAN as demonstrated by renal biopsy with total urine protein excretion ≥0.75 g per 24-hour or UPCR ≥0.75 mg/mg based on a 24-hour urine sample, and eGFR ≥30 ml/min/1.73m2; On a stable prescribed SoC regimen according to local practice listed in Section 4 of the protocol; Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at screening.
Exclusion: IgAN secondary to another condition or other causes of mesangial IgA deposition including IgA vasculitis, evidence of nephrotic syndrome within 6 months of screening, or concomitant chronic renal disease in addition to IgAN; Administration of live and live-attenuated vaccinations within 30 days prior to randomization; Active viral, bacterial or mycobacterial infections; Known hypersensitivity to atacicept or any component of the formulated atacicept; Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening); Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in the study.