This study is designed to see if the new investigational drug called ‘Verinurad’ which is not approved by any health authority (such as, the U.S. Food and Drug Administration [FDA]), is safe and effective in reducing the amount of a protein called albumin in your urine when given in combination with an approved drug called Allopurinol that is used to reduce uric acid levels. Having too much albumin in the urine is called “albuminuria” that is a sign of kidney disease and can be detected by measuring albumin levels in your urine. This study is considered to be investigational. “Investigational” means that the study drug and study drugs combination are not approved and are currently being tested.
Previous studies have shown a relationship between elevated uric acid in the blood (which is called hyperuricemia) and chronic kidney disease. However, the effects of marked reduction in uric acid on kidney function are uncertain. For this reason, this study is designed to see if Verinurad, which lowers uric acid, when given in combination with Allopurinol, which also lowers uric acid, reduces signs of kidney damage.
To do this, each patient who has agreed to participate in this study will receive study medications that contain either the investigational drug Verinurad in combination with Allopurinol, Allopurinol alone or placebo study medications. A placebo looks like the study drug, but is medication that contains no active ingredients. All study medications will be taken by mouth once a day.
The research study is planned to go on for about 2 years and include around 725 people from about 13 different countries who have kidney disease and an elevated level of uric acid in the blood.