* ORIGIN
Research type
Research Study
Full title
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)
IRAS ID
294108
Contact name
Jonathan Barratt
Contact email
Sponsor organisation
Vera Therapeutics, Inc.
Eudract number
2020-004892-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 19 days
Research summary
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 in to the urine. Ultimately IgAN patients may go on to lose kidney function (End-Stage Renal Disease (ESRD)) and may require a kidney transplant or dialysis. There is a significant unmet medical need for the treatment of IgAN, as there are currently no therapies proven effective in large randomised controlled trials. 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.
ORIGIN is a phase IIb, multicentre, randomised, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Atacicept in participants with IgAN.
The study is composed of a (up to) 4-week Screening Period, a 36-week Blinded Treatment Period (Part A), followed by a 60-week Open-Label Extension (OLE) Period (Part B), and a 12-week Safety Follow-up (FU) Period. In Part A, participants will receive 150 mg atacicept, 75 mg atacicept, 25 mg atacicept or placebo to match, given as once-weekly subcutaneous (SC) injections for 36 weeks. In Part B (OLE period), all participants will receive 150 mg atacicept, given as once-weekly SC injections for 60 weeks.
Approximately 105 randomised participants will be recruited from 60 research centres globally. The study is sponsored by Vera Therapeutics, Inc.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0300
Date of REC Opinion
9 Apr 2021
REC opinion
Further Information Favourable Opinion