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:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02757456
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged 18-95 years
2. Able to comply with the study procedures and medication
3. Written informed consent given
4. On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to recruitment
5. Cardiac evaluation within the year with adequate cardiac function to be able to undergo the exercise program
Exclusion Criteria:
1. Participation in any clinical trial using an investigational product or device during the 30 days preceding recruitment
2. Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (ie. hemiparesis, cerebellar ataxia, etc.) or dementia
3. Serum iPTH \> 250 pmol/L within 30 days prior to screening visit
4. Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to recruitment
5. Severe peripheral vascular disease
6. Severe hyperkalemia (\>6.5 mmol/L) consistently for the last 2 weeks
7. Current active cancer (excluding basal cell carcinoma of the skin)
8. Poorly controlled hypertension (systolic \> 180mmHg or diastolic \> 100mmHg) within 4 weeks prior to recruitment
9. Anticipated live donor kidney transplant or any other planned major surgery over the study duration
10. History of poor adherence to hemodialysis or medical regimen
11. Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT02757456
Study Brief:
Protocol Section:
NCT02757456