The ALIGN Study (Amendment 1)
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)
IRAS ID
292581
Contact name
Stephanie Turner
Contact email
Sponsor organisation
Chinook Therapeutics US Inc
Eudract number
2020-003084-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 29 days
Research summary
The ALIGN study is testing a study drug, atrasentan, to find out if it may work for IgA nephropathy (IgAN) patients by reducing the amount of protein in their urine and delaying the worsening of kidney function when added to ACEi/ARB therapy, the standard of care treatment for IgAN patients. The study drug will be compared with a placebo to see if taking the study drug is better than taking the placebo. All patients, including those who get randomly assigned to receive placebo, will continue to receive standard of care treatment including ACEi/ARB. Also, patients may be eligible for treatment with atrasentan for one year after the completion of the study (there will be a separate protocol for this).
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0022
Date of REC Opinion
1 Feb 2021
REC opinion
Favourable Opinion