Pharmacokinetics of Single- and Double-dose Icodextrin

NANot yet recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 15, 2024

Primary Completion Date

March 30, 2025

Study Completion Date

March 30, 2025

Conditions
Peritoneal Dialysis
Interventions
DRUG

Icodextrin

Eligible participants were admitted to the hosptial ward and used one icodextrin bag (single-dose icodextrin) or two icodextrin bags (double-dose icodextrin) on the first day, depending on their choice. Each icodextrin solution was left in the peritoneal cavity for a 8-hour dwell. The double-dose icodextrin was administered in a sequential way. After the icodextrin exchange(s), the solution was drained from the peritoneal cavity and the patients resumed dialysis using dextrose dialysate with two or three additional manual exchanges performed for the balance of the 24 hours since the icodextrin dwell was initiated. Patients were discharged and requested to return on days 7 and 14. Blood, urine and dialysate samples are collected at the time-points as required. Icodextrin and metabolites were analyzed and the pharmacokinetics profiles of single- and double-dose icodextrin were provided.

Trial Locations (1)

100034

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Peking University First Hospital

OTHER

NCT06552546 - Pharmacokinetics of Single- and Double-dose Icodextrin | Biotech Hunter | Biotech Hunter