BridgeMD
New treatment option for Chronic Kidney Disease (Stage 3-4)
Official title Equol and Vascular Function in Women With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT07194590
What this study is testing
What is Equol?
Equol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney disease (stage 3-4).
Also referred to as Equelle.
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. 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 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- History of breast cancer
See the full eligibility 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.
- 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
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 and older. 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.