Equol and vascular function in women with CKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized trial will evaluate the effect of oral equol versus placebo on vascular function in postmenopausal women with CKD stages 3–4. The study targets improvements in measures of endothelial function and arterial stiffness, areas disrupted by CKD and reduced sex hormone exposure. Participants will be adults aged 50 and older with stable kidney function, low soy intake, and no recent hormone therapy. The trial is sponsored by the University of Colorado, Anschutz Medical Campus, with NHLBI collaboration, and is conducted at a single site in Aurora, Colorado. Safety monitoring will screen for liver enzyme elevations and other adverse events related to soy-derived products.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Postmenopausal women
* Aged ≥50 years
* CKD stage 3 or 4 (eGFR with the CKD-EPI 2021 race-free equation: 15-59 mL/min/1.73m2; stable renal function in the past 3 months)
* Low habitual intake of soy (soy-related food intake \< 2 times per week assessed by Soy-Specific Food Frequency Questionnaire)
* Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study
* Ability to provide informed consent.

Exclusion Criteria:

* Patients with advanced CKD requiring chronic dialysis
* Uncontrolled hypertension in CKD group (BP \>140/90 mmHg)
* Use of any hormone replacement therapy
* Allergy and/or intolerance to soy or soy-based products
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin values 2X upper limit of normal range (upper limit of normal range AST: 117 U/L; ALT: 52 U/L; total bilirubin: 1.3 mg/dL)
* History of breast cancer
* Significant co-morbid conditions with a life expectancy of \< 1 year
* Current tobacco or nicotine use or history of use in the last 12 months
* History of kidney transplant
* History of severe congestive heart failure (i.e., ejection fraction \<35%)
* History of hospitalization within the last month
* Immunosuppressant agents taken in the past 12 months
* Known malignancy

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Ester Oh, PhD
• Email: ester.oh@cuanschutz.edu
• Phone: 303-724-3765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.