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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT03953950
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years or older (both male and female patients)
* Incidence or prevalent end-stage kidney disease patients undergoing CAPD
* Had standard dialysis prescription for at least 30 days before screening
* History of hypertension
* Stable clinical condition without any inflammation at least 4 weeks prior to enrolment
* Had an ability to understand and willingness to sign an informed consent statement
Exclusion Criteria:
* Serum potassium concentration of ≥ 5.5 milliequivalent /liter
* History of severe or active cardiovascular and/or cerebrovascular disease
* History of renal artery stenosis
* Uncontrolled hypertension
* Contraindication to angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers or mineralocorticoid receptor antagonists
* Pregnancy
* Recent PD-related peritonitis or exit-site and tunnel infection (within 2 months of screening)
* Had planned to have kidney transplantation or transfer to other PD centers with 6 months
* Prognosis for survival less than 12 months
* Any conditions (both mental or physical) that would interfere with the participant's ability to comply with the study protocol
* Any disease of the abdominal wall, such as injury or surgery, burns, hernia, dermatitis, inflammatory bowel diseases (Crohn's disease, ulcerative colitis or diverticulitis) that in the opinion of the Investigator would preclude the patient from being able to have PD
* Any intra-abdominal tumors or intestinal obstruction
* Current or recent (within 30 days) exposure to others investigational medicinal products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03953950
Study Brief:
Protocol Section:
NCT03953950