RECRUITING

Atacicept in Multiple Glomerular Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-07

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06983028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Age ≥ 10 years * Biopsy proven IgAN or IgAVN, * UPCR ≥ 0.5 g/g * eGFR≥ 20 mL/min/1.73m2 * 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) * 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
* Age ≥ 10 years
* Biopsy proven IgAN or IgAVN,
* UPCR ≥ 0.5 g/g
* eGFR≥ 20 mL/min/1.73m2
* 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)
* 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Vera Therapeutics, Inc. Clinical Trials Information

CONTACT

650-770-0077

PIONEERStudy@veratx.com

Principal Investigator

Pam Winterberg

STUDY_DIRECTOR

Vera Therapeutics

Study Locations (Sites)

Vera Therapeutics

Brisbane, California, 94005

United States

Collaborators and Investigators

Sponsor: Vera Therapeutics, Inc.

Pam Winterberg, STUDY_DIRECTOR, Vera Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-07

Study Completion Date2027-11

Study Record Updates