Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552546
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Pharmacokinetics of Single- and Double-dose Icodextrin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pharmacokinetics of Single- and Double-dose Icodextrin in Patients on Peritoneal Dialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 during long 1014 hours dwells through prolonged colloid osmosis across the peritoneal membrane in PD patients However the utilization of icodextrin is currently limited to 1 exchange per day in order to avoid plasma accumulation of maltose or other metabolites Two icodextrin bags per day has been reported to be safely prolong PD technique survival in patients in whom one icodextrin exchange provides insufficient UF A detailed evaluation of the pharmacokinetics and elimination of icodextrin and metabolites following a single exchange has been reported However characterization of the plasma kinetics metabolism and elimination of double dose icodextrin is not available yet Therefore we design the study to provide the pharmacokinetics profile of single- and double-dose icodextrin in patients on peritoneal dialysis 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
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 exchanges 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
Icodextrin was quantified in plasma urine and dialysate by exhaustive hydrolysis of all glucose polymers to glucose using the enzyme amyloglucosidase Free glucose determined prior to hydrolysis was subtracted from the result of hydrolysis to obtain the icodextrin concentration Maltose DP2 maltotriose DP3 maltotetraose DP4 were individually quantified in blood spent dialysate and urine for patients with urine output using liquid chromatography-tandem mass spectrometry LC-MSMS
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 exchanges 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
Icodextrin was quantified in plasma urine and dialysate by exhaustive hydrolysis of all glucose polymers to glucose using the enzyme amyloglucosidase Free glucose determined prior to hydrolysis was subtracted from the result of hydrolysis to obtain the icodextrin concentration Maltose DP2 maltotriose DP3 maltotetraose DP4 were individually quantified in blood spent dialysate and urine for patients with urine output using liquid chromatography-tandem mass spectrometry LC-MSMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None