RECRUITING

Atacicept in Multiple Glomerular Diseases

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.

Study Overview

Study Details

Study overview

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.

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

Atacicept in Multiple Glomerular Diseases

Condition
pMN
Intervention / Treatment

-

Contacts and Locations

Brisbane

Vera Therapeutics, Brisbane, California, United States, 94005

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.

For general information about clinical research, read Learn About Studies.

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. 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.

Ages Eligible for Study

10 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vera Therapeutics, Inc.,

Pam Winterberg, STUDY_DIRECTOR, Vera Therapeutics

Study Record Dates

2027-11