Atacicept in Multiple Glomerular Diseases (NCT06983028) | Clinical Trial Compass
RecruitingPhase 2
Atacicept in Multiple Glomerular Diseases
United States200 participantsStarted 2025-07-07
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.
Who can participate
Age range10 Years
SexALL
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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. For participants aged ≥10 to \<18 years, the average of 3 separate systolic and/or diastolic blood pressures \<95th percentile for age, gender, and height
Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome
For patients enrolling in IgAN cohorts (eligibility varies by cohort):
* Age ≥ 10 years
* Biopsy proven IgAN or IgAVN,
* UPCR ≥ 0.5 g/g
* eGFR≥ 20 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
* 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
* Biopsy diagnosis of primary MCD or FSGS (adults) or challenging clinical course with steroids in children (frequenlty relapsing, steroid-dependent, or steroid-resistant)
* UPCR ≥ 1.0 g/g at Screening,
* Evidence of anti-nephrin antibodies
Key Exclusion Criteria
* Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 3 months prior to and at Screening)
* Active viral or bacterial infections
* Existin…
What they're measuring
1
AE profile and results of routine clinical and laboratory tests
Timeframe: Baseline until end of study: 52 + 26 Weeks
2
Percent reduction in urine protein to creatinine ratio (UPCR)
Timeframe: Baseline, Week 36
Trial details
NCT IDNCT06983028
SponsorVera Therapeutics, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-11
Contact for this trial
Vera Therapeutics, Inc. Clinical Trials Information