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 |
|---|---|---|---|---|---|
2024/08/14 | Not Applicable | Not yet recruiting | |||
2024/07/09 | N/A | Recruiting | |||
2023/07/13 | Phase 4 | Not yet recruiting | |||
2023/03/22 | Phase 1 | Recruiting | |||
2023/02/10 | Phase 4 | Recruiting | First Affiliated Hospital, Sun Yat-Sen University | ||
2019/09/11 | Phase 2 | Withdrawn | |||
2014/12/17 | Not Applicable | UNKNOWN | Uppsala University | ||
2014/06/18 | Not Applicable | Completed | |||
2013/09/18 | Phase 4 | Completed | Pr Eric Goffin | ||
2011/04/29 | Not Applicable | Completed | University Hospital, Gasthuisberg |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Vantive US Healthcare LLC | 0941-0681 | INTRAPERITONEAL | 7.5 g in 100 mL | 5/7/2025 | |
| Baxter Healthcare Corporation | 0941-0679 | INTRAPERITONEAL | 7.5 g in 100 mL | 9/24/2020 | |
| Vantive US Healthcare LLC | 0941-0717 | INTRAPERITONEAL | 7.5 g in 100 mL | 5/7/2025 | |
| Vantive US Healthcare LLC | 0941-0681 | INTRAPERITONEAL | 7.5 g in 100 mL | 5/7/2025 | |
| 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 | SIN11220P | SOLUTION, STERILE | 75 g/l | 11/9/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Icodextrin Peritoneal Dialysis Solution | 国药准字H20213666 | 化学药品 | 注射剂 | 8/25/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| EXTRANEAL SOLN 7.5% | N/A | 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 | Medicine | A | 10/29/2002 | |
| EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution twin bag with drainage bag | 91430 | Medicine | A | 10/29/2002 |
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