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New treatment option for pMN
Official title Atacicept in Multiple Glomerular Diseases
ClinicalTrials.gov ID: NCT06983028
What this study is testing
What is Atacicept?
Atacicept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pmn.
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
- A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
- 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
- Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at Screening. Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic...
- Age ≥ 18 years
- Biopsy proven IgAN, IgAVN, or recurrent IgAN in kidney transplant
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
- 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...
- 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
- 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's taking place
- 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 - 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?
Study sites include Brisbane, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.