Icodextrin

Overview

Icodextrin is an iso-osmotic peritoneal dialysis solution containing glucose polymers. It is used primarily for ambulatory peritoneal dialysis (CAPD) of diabetic patients and automated peritoneal dialysis (APD) for patients with end-stage renal disease. It is injected as a solution into the peritoneal cavity. The drug is absorbed via convective transport via peritoneal lymphatic pathways.

Indication

Used for continuous ambulatory peritoneal dialysis (CAPD) of diabetic patients or automated peritoneal dialysis (APD) for the management of end-stage renal disease.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pharmacokinetics of Single- and Double-dose Icodextrin	2024/08/14	NCT06552546	Not Applicable	Not yet recruiting	Peking University First Hospital
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients	2024/07/09	NCT06492031	N/A	Recruiting	Vantive Health LLC
The Difference Between Daily and Alternative Day Use of Icodextrin	2023/07/13	NCT05943470	Phase 4	Not yet recruiting	RenJi Hospital
Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution	2023/03/22	NCT05780086	Phase 1	Recruiting	Instituto Mexicano del Seguro Social
Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis	2023/02/10	NCT05721404	Phase 4	Recruiting	First Affiliated Hospital, Sun Yat-Sen University
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine	2019/09/11	NCT04086212	Phase 2	Withdrawn	Iperboreal Pharma Srl
Does Icodextrin Reduce the Risk of Small Bowel Obstruction?	2014/12/17	NCT02318888	Not Applicable	UNKNOWN	Uppsala University
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients	2014/06/18	NCT02166359	Not Applicable	Completed	Dong-A University
Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.	2013/09/18	NCT01944852	Phase 4	Completed	Pr Eric Goffin
Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum	2011/04/29	NCT01344499	Not Applicable	Completed	University Hospital, Gasthuisberg

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
EXTRANEAL	Vantive US Healthcare LLC	0941-0681	INTRAPERITONEAL	7.5 g in 100 mL	5/7/2025
EXTRANEAL	Baxter Healthcare Corporation	0941-0679	INTRAPERITONEAL	7.5 g in 100 mL	9/24/2020
EXTRANEAL	Vantive US Healthcare LLC	0941-0717	INTRAPERITONEAL	7.5 g in 100 mL	5/7/2025
EXTRANEAL	Vantive US Healthcare LLC	0941-0681	INTRAPERITONEAL	7.5 g in 100 mL	5/7/2025
EXTRANEAL	Vantive US Healthcare LLC	0941-0719	INTRAPERITONEAL	7.5 g in 100 mL	5/7/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
EXTRANEAL PERITONEAL DIALYSIS SOLUTION 75 g/l	BAXTER HEALTHCARE SA, SINGAPORE BRANCH, BAXTER HEALTHCARE SA	SIN11220P	SOLUTION, STERILE	75 g/l	11/9/1999

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
EXTRANEAL SOLN 7.5%	N/A	Vantive Healthcare Limited	N/A	N/A	8/18/2000

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution bag	91344	Vantive Pty Ltd	Medicine	A	10/29/2002
EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution twin bag with drainage bag	91430	Vantive Pty Ltd	Medicine	A	10/29/2002

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
EXTRANEAL	Vantive ULC	02240806	Solution - Haemodialysis (Intraperitoneal)	75 G / L	1/20/2000

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
EXTRANEAL (ICODEXTRINA 7,5%) SOLUCION PARA DIALISIS PERITONEAL	Vantive Health S.L.	61860	SOLUCION PARA DIALISIS PERITONEAL	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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