Pharmacokinetics of Single- and Double-dose Icodextrin

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Aug 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes a medication called icodextrin when given to patients who are receiving peritoneal dialysis, a treatment for those with severe kidney disease. The researchers want to understand how a single dose compares to a double dose of icodextrin, which is important for knowing how well it works and how the body handles it. This information will help improve our understanding of icodextrin and its effects when used in this type of dialysis.

To participate in this study, patients must be between the ages of 65 and 85, have been on peritoneal dialysis for more than three months, and be in a stable condition. Participants will need to complete four manual exchanges of dialysis on the first day of the study. However, certain health conditions, such as allergies to icodextrin, certain cancers, or recent infections, may prevent someone from joining the trial. This study is not yet recruiting participants, but it aims to provide valuable information about icodextrin that could benefit future patients on peritoneal dialysis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with end stage renal disease, receiving peritoneal dialysis for \> 3 months, and clinically stable.
• • Suitable for 4 exchanges of manual peritoneal dialysis on the first study day.
• Exclusion Criteria:
• • History of allergic reaction to icodextrin dialysis solution or corn starch;
• • With malignant tumor receiving radiotherapy and/or chemotherapy, active hepatitis or hepatic failure, active autoimmune disease, severe digestive malabsorption or an eating disorder, or HIV/AIDS;
• • Acute systemic infection, peritonitis, catheter-related infection, cardiovascular disease, surgery, or trauma in the previous one month;
• • A high probability of receiving a kidney transplant or transferring to hemodialysis or drop-out due to socioeconomic causes within 1 months;
• • Receiving hybrid dialysis (peritoneal dialysis combined with hemodialysis);
• • Pregnant or lactating female;
• • Having used icodextrin within previous 30 days；
• • Peritoneal catheter dysfunction；
• • Not suitable for enrollment assessed by researchers, including those unable followed the study protocol, or enrolled in other intervention studies, or with other reasons considering not suitable for enrollment by researchers.