Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis

Launched by FIRST AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Feb 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a solution called icodextrin can help patients on incremental peritoneal dialysis (a type of kidney treatment) delay the need to switch to a higher dose of dialysis. The researchers believe that using icodextrin may allow patients to have fewer dialysis sessions while still getting adequate treatment, thus extending the time before they need to increase their dialysis dose. The trial will also look at how icodextrin affects patients' overall health, including issues like infections and hospitalizations.

To participate in this study, you need to be at least 18 years old and have certain kidney function levels. You should be able to follow the study schedule and attend regular check-ups every two months. Participants will be divided into two groups: one will receive icodextrin, and the other will receive a different solution for comparison. Throughout the study, doctors will monitor your health and fluid balance. This research aims to improve dialysis treatment strategies and provide better care for patients with some kidney function still working.

Gender

ALL

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.