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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Vera Therapeutics
RECRUITING
Brisbane
Contact Information
Primary
Vera Therapeutics, Inc. Clinical Trials Information
clinicaltrials@veratx.com
(650)770-0077
Time Frame
Start Date: 2025-05-29
Estimated Completion Date: 2027-09
Participants
Target number of participants: 90
Treatments
Experimental: Atacicept Arm 1
Atacicept dose A administered subcutaneous (sc) injection monthly
Experimental: Atacicept Arm 2
Atacicept dose B administered subcutaneous (sc) injection monthly
Experimental: Atacicept Arm 3
Atacicept dose C administered subcutaneous (sc) injection monthly
Experimental: Atacicept Arm 4
Atacicept dose D administered subcutaneous (sc) injection weekly
Experimental: Atacicept Arm 5
Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections
Related Therapeutic Areas
Sponsors
Leads: Vera Therapeutics, Inc.

This content was sourced from clinicaltrials.gov