Recruiting NCT06983028

Atacicept in Multiple Glomerular Diseases

Phase II Interventional pMN IgAN Nephrotic Syndrome MCD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Atacicept.
Who it may be relevant to: Registry conditions: pMN, IgAN, Nephrotic Syndrome, MCD. Basic parameters: from 2 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)

A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.

Detailed description

The purpose of this study is to evaluate the safety and efficacy of Atacicept in multiple autoimmune glomerular diseasing including:

* IgAN (IgA Nephropathy) * pMN (Primary Membranous Nephropathy) * MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis)

AE profile and results of routine clinical and laboratory tests [Time frame: Baseline until end of study: 52 + 26 Weeks]
Percent reduction in urine protein to creatinine ratio (UPCR) [Time frame: Baseline, Week 36]

Secondary outcome measures (2)

Changes from baseline estimated glomerular filtration rate (eGFR). [Time frame: Baseline, Week 36, Week 52]
Change in disease-specific antibodies [Time frame: Baseline through 52 Weeks]

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):

For patients enrolling in pediatric IgAN Cohorts (eligibility varies by cohort):

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT06983028 · VT-001-0060