Active Digestion, Kidneys & Other Organs NIHR-supported project Lungs & Breathing

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)

Funder NIHR (part of DHSC)
Recipient organisation NIHR Guy's and St Thomas' Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Dec 2028

In plain English

AI plain-English summary

A drug called atacicept is being tested in a large, global clinical trial to see if it can slow or stop kidney damage in people with IgA nephropathy, a chronic autoimmune disease that can lead to kidney failure. IgA nephropathy occurs when the immune system deposits a protein called IgA in the kidney’s filters, causing inflammation, scarring, and gradual loss of function. Current treatments—blood pressure control and immune suppression—are limited and often ineffective. Atacicept works by blocking the production of IgA itself, targeting the root cause rather than just managing symptoms. If the trial succeeds, atacicept could become the first therapy to directly reduce the IgA deposits that destroy kidney tissue. For patients, this could mean delaying or avoiding dialysis and transplantation—treatments that currently affect hundreds of thousands of people in the UK alone. The study involves 376 participants across up to 250 centres worldwide, with a 104-week double-blind period followed by a 52-week open-label extension. The primary endpoints are reductions in proteinuria and preservation of renal function.

View original technical description
Immunoglobulin (Ig) A nephropathy (IgAN) or Berger’s disease, is a chronic kidney disorder that occurs when Immunoglobulin A (IgA) builds up in the glomeruli (filters) of the kidney. Over time, these IgA deposits can inflame, damage and scar the glomeruli, causing leakage of blood and protein into the urine. Ultimately IgAN patients may go on to lose kidney function and may require a kidney transplant or dialysis. There is a significant unmet medical need for the treatment of IgAN. Current management includes blood pressure control, renin-angiotensin system (RAS) blockade and in rare instances combination immunosuppression with cyclophosphamide and corticosteroids for rapidly progressive IgAN. VT-001 (also known as Atacicept) is thought to help regulate the immune system by reducing and blocking plasma cells and B-cells from producing IgA.This is a multi-part study comprising of the original Phase 2b study (ORIGIN) and the addition of a separate Phase 3 study (ORIGIN 3). The Phase 3 study is a multicenter, randomized, double-blind, placebo-controlled trial. The objectives of the Phase 3 study will be to determine the effect of atacicept on proteinuria and preservation of renal function in subjects with IgAN.The study is composed of a (up to) 4-week Screening Period, a 104-week Double-Blind Treatment Period (Part C), a 52-week Open-Label Extension (Part D) and 26 weeks of follow-up. Subjects who complete the 104-week Double-Blind Period on treatment will be eligible for open-label atacicept 150 mg for an additional 52 weeks (Open-Label Extension). Approximately 376 randomized participants will be recruited from up to 250 research centers globally. The study is sponsored by Vera Therapeutics, Inc.

Researchers

Dimitrios Moutzouris (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

ORIGIN 3 A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)
A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)
Origin A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)
A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

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