A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricemia
Protocol No: D5495C00002, CGIRB Protocol # 20191106
Sponsor: AstraZeneca AB
Investigator: Kianoosh Kaveh, DO
You are invited to take part in this research study because you have a history of a chronic kidney disease (CKD). The reason for the study is to try to find a more effective treatment for your kidney problem. Whether you take part or not is completely up to you. Take the time you need to read this information and ask your study doctor any questions. You can talk to your family, friends, or family doctor before you decide. If you decide to take part, you must sign this form to show that you agree to take part, and to allow us to use your personal information. If you do not sign this form, you won’t be able to take part in this study.
Why are we doing this research study?
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. Allopurinol is used to reduce uric acid levels. Having too much albumin in the urine is called “albuminuria”. Albuminuria is a sign of kidney disease. 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.
Will I be paid to take part?
AstraZeneca will refund reasonable expenses including travel or parking that you incur because of this study if allowed and approved by local regulations. You will be reimbursed $65 per completed visit.
Questions or concerns?
Your answers on the questionnaire are not set in stone. If you are unsure about an entry, simply make a note in the Additional Questions or Concerns field at the bottom of the form.