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

Investigating the Safety and Effects of an Investigational Medication in Autoimmune Kidney Diseases

M
Myda Khalid

Primary Investigator

Enrolling By Invitation
10 years or above
All
Phase 2
5 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

The study will assess the safety and efficacy of atacicept in multiple autoimmune glomerular diseases including IgAN (IgA Nephropathy), pMN (Primary Membranous Nephropathy) and MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis) in participants ages 10 and above with weekly SC injections:

(1) selected subgroups of participants with
immunoglobulin A (IgA) nephropathy (IgAN) or immunoglobulin A vasculitis with
nephritis (IgAVN) enrolled into 8 cohorts; 

(2) participants with anti-PLA2R
associated membranous nephropathy (PLA2R-MN) enrolled into 2 cohorts;

(3) participants with idiopathic/primary nephrotic syndrome (MCD/FSGS) with
anti-nephrin antibodies enrolled into 2 cohorts. 

All participants will receive atacicept. 

Participants will be treated in this study for 52 weeks.  

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Autoimmune Glomerular Disease, IgAN, IgAVN, pMN, MCD, FSGS, Primary nephrotic syndrome, Riley
  • Age: 10 years or above
  • Gender: All

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
  • Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 3 months 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
  • Known hypersensitivity to atacicept or any component of the formulated atacicept
  • Additional criteria apply to each cohort/disease.

This study investigates the safety and effects of an investigational medication in people with autoimmune kidney diseases. These conditions include IgA Nephropathy (IgAN), Primary Membranous Nephropathy (pMN), and Minimal Change Disease/Focal Segmental Glomerulosclerosis (MCD/FSGS). Autoimmune kidney diseases occur when the body's defense system attacks the kidneys, causing damage. This study aims to see if the investigational medication can reduce protein in urine and help keep kidney function stable.

Participants will receive the investigational medication through weekly injections for 52 weeks. The study includes different groups called cohorts, each focusing on a specific disease. All participants will be monitored to assess the safety and effects of the treatment. The study will not change any other treatments participants are currently receiving.

  • Who can participate: Participants must be 10 years or older and weigh at least 40 kg. They should have a diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome. Blood pressure and kidney function requirements apply, and additional criteria vary by specific disease cohort.
  • Study details: Participants will receive weekly injections of the investigational medication for a total of 52 weeks. They will continue their usual care and be monitored for safety and effects of the treatment.
  • Study timelines: The study will last 52 weeks.
Updated on 23 Dec 2025. Study ID: PNEPH-VT-PIONEER, 27222
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only