Using icodextrin to delay full dose dialysis in patients on incremental peritoneal dialysis

Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis: A Randomized Controlled Trial

This study is testing if icodextrin can help patients on low dose peritoneal dialysis delay moving to full dose dialysis during their first year of treatment.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 194 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05721404 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of icodextrin in patients undergoing incremental peritoneal dialysis (PD) to determine if it can postpone the transition from low dose to full dose dialysis within the first year. Participants will be randomly assigned to receive either icodextrin or a control solution while following a prescribed incremental PD regimen. The study will monitor clinical outcomes, including fluid status and complications such as peritonitis and hospitalization. Patients will be followed every two months to assess their fluid balance and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are starting incremental peritoneal dialysis and meet specific kidney function criteria.

Not a fit: Patients who have previously undergone kidney transplantation or those currently receiving hemodialysis will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help patients maintain effective dialysis with reduced glucose exposure, potentially improving their quality of life.

How similar studies have performed: While the use of icodextrin in dialysis has been explored, this specific approach of delaying full dose dialysis in incremental PD is novel and has not been extensively tested.

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Xiao Yang, Doctor — First Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Xiao Yang, Doctor

Conditions: Peritoneal Dialysis, peritoneal dialysis, incremental peritoneal dialysis, icodextrin