Atacicept: Atacicept 150 mg SC QW via pre-filled syringe
Study summary
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
Eligibility
Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Weight of at least 40 kg
* On a stable prescribed standard of care (SoC) treatment regimen according to local guidelines and the specific requirements for each disease
* Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at Screening.
Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome
For patients enrolling in IgAN cohorts (eligibility varies by cohort):
* Age ≥ 18 years
* Biopsy proven IgAN, IgAVN, or recurrent IgAN in kidney transplant
* UPCR ≥ 0.5 g/g or UPE ≥ 0.5 g/day on 24h urine
* eGFR≥ 20 mL/min/1.73m2
For patients enrolling in pediatric IgAN Cohorts (eligibility varies by cohort):
* Age ≥ 2 years and \< 18 years
* Biopsy proven IgAN or IgAVN
* On stable prescribed regimen of RAASi (or SoC) for at least 8 weeks
* UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/d on 24h urine
* eGFR≥ 30 mL/min/1.73m2
For patients enrolling in pMN cohorts (eligibility varies by cohort):
* Age ≥ 18 years
* Biopsy-proven pMN
* Anti PLA2R antibodies ≥ 25 RU/mL
* UPCR ≥ 1.5 g/g or UPE ≥ 1.5 g/d on 24h urine
* At low risk for spontaneous remission (based on severity or duration of disease)
For patients enrolling in Nephrotic Syndrome cohorts (MCD, FSGS, or pediatric idiopathic nephrotic syndrome):
* Age ≥ 10 years
* eGFR ≥30 mL/min/1.73m2
* Adults with biopsy diagnosis of primary MCD or FSGS (adults) or children with challenging clinical course with steroids (frequenlty relapsing, steroid-dependent, or steroid-resistant)
* UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/d on 24h urine
* Evidence of anti-nephrin antibodies
Key Exclusion Criteria:
* Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 12 weeks prior to and at Screening)
* Active viral or bacterial infections
* Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
* Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
* Immunosuppressant medications within 4 weeks prior to dosing with atacicept (except transplant maintenance immunosuppression).
* Known hypersensitivity to atacicept or any component of the formulated atacicept
* Additional criteria apply to each cohort/disease.
Primary outcome measure(s)
AE profile and results of routine clinical and laboratory tests — Baseline until end of study: 52 + 26 Weeks Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs
Percent reduction in urine protein to creatinine ratio (UPCR) — Baseline, Week 36 Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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