PMN study: Atacicept
Official title Atacicept in Multiple Glomerular Diseases
ClinicalTrials.gov ID: NCT06983028
What this study is testing
What is Atacicept?
An investigational once‑weekly injectable medicine being studied for autoimmune kidney diseases such as primary membranous nephropathy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine how well atacicept works and how safe it is for people with these kidney diseases.
- Who it's for
- Participants with primary membranous nephropathy, IgA nephropathy, nephrotic syndrome, minimal change disease, or focal segmental glomerulosclerosis.
- What's involved
- Participants will receive the drug atacicept and attend scheduled visits for medical assessments and safety monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- 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
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
- 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
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Brisbane, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Brisbane, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.