> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/atacicept-in-multiple-glomerular-diseases-c0bd4719-5c03-432d-be22-82af920d1552
> Record changed: 2026-11-04

# Atacicept in Multiple Glomerular Diseases

NCT06983028

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

Participants

250

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

Lead sponsor

Vera Therapeutics, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

Start date

2025-07-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Title and summary

**Summary**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Short title**

Atacicept in Multiple Glomerular Diseases

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Official title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Status and phase

**Control arm**

Open label

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Dates

**Completion date**

2027-11-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**First posted**

2025-05-21

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Registry last updated**

2026-06-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Primary completion date**

2027-11-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Start date**

2025-07-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Size and sites

**Participants**

250

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Planned participants**

250

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Lead sponsor**

Vera Therapeutics, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Identifiers

**Registry ID**

NCT06983028

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**ClinicalTrials.gov ID**

NCT06983028

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Study design

**Allocation**

Not randomised

**Model**

Single group

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Outcomes

### Primary outcomes

1. AE profile and results of routine clinical and laboratory tests  
Timeframe: 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
2. Percent reduction in urine protein to creatinine ratio (UPCR)  
Timeframe: Baseline, Week 36  
Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36

### Secondary outcomes

1. Changes from baseline estimated glomerular filtration rate (eGFR).  
Timeframe: Baseline, Week 36, Week 52  
Changes from baseline in estimated glomerular filtration rate (eGFR).
2. Change in disease-specific antibodies  
Timeframe: Baseline through 52 Weeks  
IgAN: Percent change from baseline galactose-deficient IgA1 (GdIgA1) levels at 36 and 52 weeks. pMN: Percent change from baseline in anti-PLA2R antibody levels at 4, 8, 12, 36, and 52 weeks. MCD/FSGS: Percent change from baseline anti-nephrin antibody levels at 4, 8, 12, 36, and 52 weeks (exploratory).

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Eligibility

**Sex**

All

**Age groups**

Children, Adults, Older adults

**Minimum age**

2 Years

**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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Sites

- Vera TherapeuticsBrisbane, United StatesRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983028)

## Related records

### Drugs (1)

- [Atacicept](https://trialight.com/data/asset/atacicept-58997791-8042-4d0f-ac69-564cf9e78d1d.md)

### Lead sponsors (1)

- [Vera Therapeutics, Inc.](https://trialight.com/data/company/vera-therapeutics-inc-fd62720a-49c4-4898-9da6-4a7eb76bbc32.md)

### Conditions (8)

- [Autoimmune disease](https://trialight.com/data/condition/autoimmune-disease-8a8fd8aa-2d04-5f24-b839-ba96a70c11e9.md)
- [Glomerulonephritis](https://trialight.com/data/condition/glomerulonephritis-006ca4c9-5ece-5cd3-941f-f0e39f792dbc.md)
- [IgA glomerulonephritis](https://trialight.com/data/condition/iga-glomerulonephritis-f6f68a56-7253-54d9-9456-5d9ece4d1a52.md)
- [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md)
- [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md)
- [Macular corneal dystrophy](https://trialight.com/data/condition/macular-corneal-dystrophy-ea584523-cd7f-594c-a5e1-046755e8019a.md)
- [Nephritis](https://trialight.com/data/condition/nephritis-58f31f23-e5c1-5fa9-a945-53ea4e1ef653.md)
- [Nephrotic syndrome](https://trialight.com/data/condition/nephrotic-syndrome-c47dd11b-4c29-5968-aab7-a1f91392b5ac.md)

### Targets (2)

- [TNFSF13](https://trialight.com/data/target/tnfsf13-45f49145-416e-5e16-b03b-b1de0275c8c9.md)
- [TNFSF13B](https://trialight.com/data/target/tnfsf13b-a5ea2503-7758-5b9b-93fc-c033ce6f46e2.md)

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