Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT05422534
Eligibility Criteria:
Inclusion Criteria:
* Subjects age 18 to 75 years
* On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis).
* Clinically stable, adequately dialyzed (single-pool Kt/V \>1.2) thrice weekly, for at least 3 consecutive months prior to the study (only applicable for patients with ESRD on maintenance hemodialysis)
Exclusion Criteria:
* Body mass index \> 35 mg/kg2
* History of functional transplant less than 6 months prior to study
* Use of immunosuppressive drugs within 1 month prior to study
* Active connective tissue disease
* Acute infectious disease within 1 month prior to study
* AIDS (HIV seropositivity is not an exclusion criterion)
* Acute myocardial infarction or cerebrovascular event within 3 months
* Uncontrolled blood pressure
* New or worsening mitral regurgitation murmur
* Hypotension, bradycardia, or tachycardia
* Prolonged ongoing (greater than 20 minutes) angina at rest
* Angina at rest with transient ST changes greater than 0.05 mV on ECG
* Sustained ventricular tachycardia on ECG
* Elevated cardiac enzymes (e.g., troponin Tor I greater than 0.1mg/ml)
* Advanced liver disease, with a modified Child-Turcotte-Pugh score equal or greater than 10.
* Gastrointestinal dysfunction requiring parental nutrition
* Active malignancy excluding basal cell carcinoma of the skin
* Ejection fraction less than 30%
* Pre-dialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
* Anticipated live donor kidney transplant
* History of poor adherence to hemodialysis or medical regimen
* Inability to provide consent
* Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies.
* Inability to perform exercise
* Contraindication for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05422534
Study Brief:
Protocol Section:
NCT05422534