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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT02358967
Eligibility Criteria:
Inclusion Criteria:
* Patient is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 18 years and above. Undergoing chronic hemodialysis treatment for more than 3 months (life expectancy \> 1 year).
* Able and willing to comply with all trial requirements.
* Willing to allow his or her /Physician/Nephrologist/General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Exclusion Criteria:
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
* History of functional kidney transplant 6 months before study entry; anticipated live donor kidney transplant over the study duration;
* Participants who are taking vitamin E- containing supplements \>60 IU/d during the past 30 days
* History of poor adherence to hemodialysis or medical regimen
* Participants who are currently on active treatment for cancer, excluding basal cell carcinoma of the skin
* Participants who have been diagnosed as HIV/AIDS and/or on the anti-HIV therapy. (HIV seropositivity is not an exclusion criterion)
* Patients taking anti-inflammatory medication, except aspirin\<325 mg/d, over the past 30 days
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
* Participants who are receiving nutritional support (i.e. enteral and intra-venous route)
* Patients using a temporary catheter for dialysis access at baseline or patients receiving a graft/fistula within the 6-month study period
* More than two hospitalizations within the last 90 days or one hospitalization within the 30 days preceding enrollment
* Any other significant disease or disorder which, in the opinion of their nephrologist, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02358967
Study Brief:
Protocol Section:
NCT02358967