NCT07194590 Equol and Vascular Function in Women With Chronic Kidney Disease
| NCT ID | NCT07194590 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Chronic Kidney Disease (Stage 3-4) |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2026-02-19 |
| Primary Completion | 2030-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 74 participants in total. It began in 2026-02-19 with a primary completion date of 2030-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in nephrology focuses on male patients, and studies on women's vascular health are limited. Establishing effective therapies for improving vascular function and reducing CVD risk in women with CKD is a high research priority of the NIH. Equol contributes to improvement in vascular function, mediated in part by its anti-oxidative and anti-inflammatory properties. However, there is no information on the effect of equol on vascular function in women with CKD. The proposed project aims to determine the effect of 12 weeks of oral equol supplementation on vascular function in postmenopausal women with CKD.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07194590 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Chronic Kidney Disease (Stage 3-4). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07194590 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07194590 currently recruiting?
Yes, NCT07194590 is actively recruiting participants. Contact the research team at ester.oh@cuanschutz.edu for enrollment information.
Where is the NCT07194590 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07194590 clinical trial?
NCT07194590 is sponsored by University of Colorado, Denver. The trial plans to enroll 74 participants.
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