RECRUITING

Monthly Dosing of Atacicept in IgAN

Conditions

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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

This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept

Official Title

A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN

Quick Facts

Study Start:2025-05-29

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07020923

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments * Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments * Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years * Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample * eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) * On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1	* IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis * Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening) * Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<3.0 g/dL in association with UPCR \>3.5 mg/mg) * Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants * Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)

Inclusion Criteria

Exclusion Criteria

* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
* Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
* Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
* Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
* eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1

* IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis
* Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
* Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<3.0 g/dL in association with UPCR \>3.5 mg/mg)
* Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
* Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)

Contacts and Locations

Study Contact

Vera Therapeutics, Inc. Clinical Trials Information

CONTACT

(650)770-0077

clinicaltrials@veratx.com

Principal Investigator

Zeeshan Khawaja

STUDY_DIRECTOR

Vice President, Clinical Development

Study Locations (Sites)

Vera Therapeutics

Brisbane, California, 94005

United States

Collaborators and Investigators

Sponsor: Vera Therapeutics, Inc.

Zeeshan Khawaja, STUDY_DIRECTOR, Vice President, Clinical Development

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 Date2025-05-29

Study Completion Date2027-09

Study Record Updates

Study Start Date2025-05-29

Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

IgA Nephropathy (IgAN)
Berger Disease