Status:
NOT_YET_RECRUITING
Equol and Vascular Function in Women With Chronic Kidney Disease
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Kidney Disease (Stage 3-4)
Vascular Function
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
Brief Summary
The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, whi...
Detailed Description
Patients with chronic kidney disease (CKD) have a significantly higher risk of cardiovascular diseases (CVD). Indeed, CVD is the leading cause of death in these patients. A primary reason why CKD so g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2030
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT07194590
Start Date
December 1 2025
End Date
November 30 2030
Last Update
September 26 2025
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