ARTEMIS-IGAN
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN)
IRAS ID
242364
Contact name
Cheung Chee Kay
Contact email
Sponsor organisation
Omeros Corporation
Eudract number
2018-000075-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 16 days
Research summary
Participants in this study have IgA nephropathy, a kidney disease that occurs when an antibody called immunoglobulin A (IgA) lodges in the kidneys. This results in local inflammation that, over time, may interfere with the kidneys' ability to filter waste from the blood. IgA nephropathy usually progresses slowly over many years; some people leak blood in their urine without developing problems, some may recover, and others can develop end-stage kidney failure. No cure exists for IgA nephropathy, but certain medications can slow it down. Keeping blood pressure under control and reducing cholesterol levels also slow down the disease. Researchers want to find out if giving the study drug, OMS721, to people with IgA Nephropathy will reduce levels of protein in the urine, is safe and if patients can tolerate the drug. OMS721 works by blocking a substance in the blood that may cause kidney damage from IgA nephropathy. There will be two groups of participants in this study; one will take the OMS721, the other will be given a placebo which looks like the OMS721, but does not have any active ingredient. Current treatment options are limited in this group of patients; usually steroid and immunosuppressant medication which all have undesirable side effects, and education regarding diet and lifestyle. The information collected from this study may enable doctors to make better decisions about how to treat patients with IgA nephropathy.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0282
Date of REC Opinion
6 Nov 2019
REC opinion
Further Information Favourable Opinion