Pharmacokinetics of Single- and Double-dose Icodextrin
ConditionPeritoneal Dialysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorPeking University First Hospital
About this trial
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 pharmacology of icodextrin following its intraperitoneal administration and fills the gaps in our understanding of the fate of icodextrin and the metabolic consequences of icodextrin and its metabolites.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Icodextrin
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov