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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT02378350
Eligibility Criteria:
Inclusion Criteria:
1. Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)
2. Male or female subjects aged 18 years or older at the time of randomization
3. Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF
4. Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF
5. Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD
6. Subjects who are able to adhere to the study visit schedule and other protocol requirements
7. Subjects who are able to come to HD clinics as required by the protocol
8. Subjects who, as judged by the Investigator, are expected to remain on dialysis for at least 48 weeks
9. Subjects who have normal liver function, as judged by the Investigator
10. Female subjects of childbearing potential must have negative serum or urine pregnancy test at Screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the Investigator, while in the study
Exclusion Criteria:
1. Subjects who are HIV positive
2. Subjects who have already received maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤4 weeks before Screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities or fluid overload
3. Subjects who have an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study
4. Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening
5. Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
6. Subjects who are currently using any investigational drug
7. Subjects who are currently enrolled in other clinical studies
8. Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol
9. Subjects who are not eligible for either PD or HD, as judged by the Investigator, due to:
* Peritoneal dialysis: documented extensive intra-peritoneal adhesions or other conditions in which PD is contraindicated
* Hemodialysis: severe cardiac instability or other conditions in which HD is contraindicated
10. Subjects who have a malignancy requiring chemotherapy or radiation therapy
11. Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration
12. Subjects who have a life expectancy of \< 48 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02378350
Study Brief:
Protocol Section:
NCT02378350