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New treatment option for Chronic Kidney Diseases
Official title Acute Equol Supplementation and Vascular Function in Women With and Without CKD
ClinicalTrials.gov ID: NCT06128278
What this study is testing
What is S-equol?
S-equol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 69, women only. Healthy volunteers may be eligible.
You may be able to join if
- Postmenopausal (50-69 y) women
- Women with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021...
- Women without CKD (eGFR \>60 ml/min/1.73m2) must be healthy (free from hypertension, kidney disease, CVD, diabetes, and other chronic disease as...
You likely can't join if
- Use of HRT or has used HRT for \<6 months prior to enrollment
- Advanced CKD requiring dialysis
- History of kidney transplant
- Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease)
- Current tobacco or nicotine use or history of use in the last 12 months
- Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
See the full eligibility criteria
- Postmenopausal (50-69 y) women
- Women with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 equation
- Women without CKD (eGFR \>60 ml/min/1.73m2) must be healthy (free from hypertension, kidney disease, CVD, diabetes, and other chronic disease as assessed by self-report, medical history, and screening labs).
- Use of HRT or has used HRT for \<6 months prior to enrollment
- Advanced CKD requiring dialysis
- History of kidney transplant
- Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease)
- Current tobacco or nicotine use or history of use in the last 12 months
- Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
- Marijuana use within 2 weeks prior to testing
- Consumption of soy and soy-based products 3 days prior to testing
- Uncontrolled hypertension in CKD group (BP\>140/90 mmHg)
- Atrial fibrillation
- Active infection or antibiotic therapy
- Hospitalization in the last month
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years to 69 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.