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New treatment option for Peritoneal Dialysis
Official title Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis
ClinicalTrials.gov ID: NCT05721404
What this study is testing
What is Icodextrin Peritoneal Dialysis Solution?
Icodextrin Peritoneal Dialysis Solution is an investigational medicine, given as an once-weekly, being studied as a potential treatment for peritoneal dialysis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- We hypothesize incremental peritoneal dialysis (incremental PD) protocol with icodextrin solution will help patients to achieve adequate ultrafiltration and adequate dialysis with less glucose exposure by manipulating a low frequency of exchanges, therefore prolong the time from incremental protocol to full dose protocol (Full dose dialysis is defined as a dialysis dose of more than 8 L (4 exchanges of 2 L) per day). The goal of this clinical trial is to investigate the effect of icodextrin postponing the shift of low dose to full dose dialysis in the first year of incremental peritoneal dialysis.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.