Status:
NOT_YET_RECRUITING
Pharmacokinetics of Single- and Double-dose Icodextrin
Lead Sponsor:
Peking University First Hospital
Conditions:
Peritoneal Dialysis
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The study aims to provide the pharmacokinetics profiles of single- and double-dose icodextrin in patients on peritoneal dialysis (PD). It may expand the available knowledge of the clinical pharmacolog...
Detailed Description
Icodextrin is confirmed safe and effective as an alternative osmotic agent by numerous clinical studies. Due to its high molecular weight, icodextrin exerts its effect to enhance ultrafiltration (UF) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06552546
Start Date
August 15 2024
End Date
March 30 2025
Last Update
August 14 2024
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034