After menopause, changes in hormones can affect how blood vessels work and can raise the risk of heart and blood vessel problems. This risk can be higher for women with chronic kidney disease. Some hormone treatments may help. This study is being done to learn whether equol, a supplement made from soy, can help blood vessels work better in postmenopausal women with chronic kidney disease (CKD). About 74 people from your area will take part in this study. If you wish to join, you will first have a screening visit. At this visit, the study team will review your health history, take your vital signs, and blood and urine tests. If you qualify, and choose to join, you will be in the study for about 12 weeks. You will be placed into one of two groups by chance, like flipping a coin. One group will get 5mg of equol capsules to take 2 times a day, and the other group will get 5 mg capsules to take 2 times a day of a placebo. A placebo looks the same as the study medicine but has no active ingredient. Neither you nor the study team will know which group you are in. During the study, you will come to the Renal Research Clinic on the Anschutz Medical Campus for 5 in-person visits. You will also have 3 remote, check-in visits. Study visits include vital signs, blood draws, urine collection, answering surveys, and tests to see how well your blood vessels work using a painless noninvasive ultrasound. You also may be asked to take part in optional tests. These include an extra blood vessel cell collection, tests to measure blood flow to the brain, and computer-based memory and thinking tests. You can choose whether or not to take part in these optional tests. You will be paid $75 for your baseline visit and $75 for your end of study visit, for a total of $150 for completing the main study. If you complete the optional blood vessel cell collection, you will receive an extra $100. If you complete the optional brain blood flow testing, you will receive an extra $50. If you complete the optional memory and thinking tests, you will receive an extra $50.

Who can Participate

You may be able to join this study if you are a woman age 50 or older and are postmenopausal. You must have stage 3 or 4 CKD. Your weight should have stayed the same over the past 3 months, and you are willing to keep your weight stable during the study. You cannot join this study if your blood pressure is not well controlled, meaning it is higher than 140/90. You also cannot join if you use hormone replacement therapy, have used tobacco or nicotine in the past 12 months, or have had a kidney transplant. At your first visit, the study team will check to make sure you meet all the requirements to join the study.

Study ID