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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yxiao@mail.sysu.edu.cn
• Phone: 0086-20-87608879

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mobile training system for patients on peritoneal dialysis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.