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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT05721404
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old;
* The estimated glomerular filtration rate (eGFR) ≥ 3ml/min·1.73m2 when enrolled;
* The 24-hour urine volume ≥ 500ml when enrolled;
* The patient or his lawful representative is able to receive and complete training of home peritoneal dialysis;
* Patients were able to follow the follow-up schedule and other requirements of the study;
* Patients can come to the peritoneal dialysis center for regular follow-up (once every 2 months or more);
* Participants were expected to remain on peritoneal dialysis for at least 13 months;
* Patients with good compliance;
* Informed consent was obtained.
Exclusion Criteria:
* Treated with both peritoneal dialysis and hemodialysis;
* Patients who have previously received a kidney transplant and have been receiving immunosuppressive therapy;
* Contraindications to bioelectrical impedance analysis (BIA) testing (e.g., amputation, use of a pacemaker or prosthesis);
* Allergy to Icodextrin, starch and starch products, or suffer from glycogen storage disease;
* Contraindications for the use of icodextrin;
* HIV-positive participants;
* Patients with tumors or other serious diseases have a life expectancy of less than one year;
* Mental illness that interferes with the patient's understanding of the test requirements and completion of the test process;
* Chronic wasting diseases such as tuberculosis, cirrhosis, hematological or other malignancies;
* Patients who are pregnant, intending to become pregnant, or breastfeeding during the study period;
* The patients had a history of drug abuse or alcoholism 2 years before the screening period;
* Patients who are unwilling or not expected to fully comply with the visits and evaluations required by the protocol;
* Patients who, in the investigator's judgment, have other serious or acute medical conditions that may prevent them from participating in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05721404
Study Brief:
Protocol Section:
NCT05721404