Drugs / Icodextrin
Icodextrin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | EXTRANEAL | — | 2004-12-17 | fda.gov ↗ |
| Approved | US (FDA) | EXTRANEAL | — | 2002-12-20 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05780086 | Feb → Aug 2023 | chronic kidney disease | Mexican Social Security Institute | Unknown | No outcome recorded |
| Phase 1 | NCT05185999 | Oct 2022 → Oct 2023 | chronic renal failure syndrome | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00368641 | Aug 2006 → Apr 2008 | congestive heart failure | Vantive Health LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT01219959 | Oct 2010 → Jul 2011 | diabetes mellitus, end stage renal failure | Vantive Health LLC | Completed | Met primary |
| Phase 3 | NCT00567398 | Apr 2008 → Jul 2011 | diabetes mellitus, end stage renal failure | Vantive Health LLC | Completed | Met primary |
| Phase 46 trials · 1 missed | ||||||
| Phase 4 | NCT05943470 | Aug → Dec 2023 | — | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05721404 | May 2023 → Apr 2027 expected | — | First Affiliated Hospital, Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT01944852 | Mar 2013 → Feb 2020 | impaired renal function disease | Pr Eric Goffin | Completed | No outcome recorded |
| Phase 4 | NCT01044446 | Jan 2010 → Aug 2012 | peritonitis | Chinese University of Hong Kong | Completed | Missed primary |
| Phase 4 | NCT00397358 | Nov 2006 → Jun 2007 | hypertriglyceridemia | Vantive Health LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00725517 | Dec 2005 → Feb 2007 | chronic kidney disease | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07168343 | Feb 2026 → Jun 2028 expected | — | National University Health System, Singapore | Not yet recruiting | No outcome recorded |
| — | NCT06552546 | Aug 2024 → Mar 2025 overdue | — | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| — | NCT02166359 | Jun 2014 → Mar 2019 | end stage renal failure | Dong-A University | Completed | No outcome recorded |
| — | NCT01170858 | Aug 2010 → Aug 2014 | end stage renal failure | Yonsei University | Completed | No outcome recorded |
| — | NCT02318888 | Dec 2009 → Dec 2022 | — | Uppsala University | Unknown | No outcome recorded |
| — | NCT00119990 | Jan 2006 → Jan 2009 | — | University of Aarhus | Terminated | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT04086212 Comparator | Oct 2019 → Dec 2022 | end stage renal failure | Iperboreal Pharma Srl | Withdrawn | No outcome recorded |
| Phase 2 | NCT01242904 Comparator | Sep 2010 → Feb 2015 | end stage renal failure | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 2 | NCT00755456 Comparator | Jan 2008 → Sep 2012 | end stage renal failure | Iperboreal Pharma Srl | Completed | Missed primary |
| Phase 2 | NCT00755404 Comparator | Jun 2007 → Oct 2013 | diabetes mellitus, end stage renal failure | Iperboreal Pharma Srl | Withdrawn | No outcome recorded |
| Phase 3 | NCT01124227 Comparator | Apr 2010 → Sep 2016 | congestive heart failure | Martini Hospital Groningen | Terminated | No outcome recorded |
| — | NCT01758627 Background | Dec 2013 → Oct 2015 | advanced heart failure, chronic kidney disease | Yonsei University | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | icodextrin | “At least one daily exchange of icodextrin PD solution will be provided to PD group.” NCT01758627 ↗19“1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange” NCT00755404 ↗ “1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange” NCT00755456 ↗ “Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution” NCT04086212 ↗ |
| Known as | Extraneal | “Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution” NCT04086212 ↗5“Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution” NCT00397358 ↗ “Icodextrin (Extraneal) for long night dwell” NCT05721404 ↗ |
| Known as | Icodextrina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201472 ↗ |
| Known as | Icodextrine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201472 ↗ |
| Modality | Other / unclassified | “Icodextrin is a mixture of high molecular weight, water soluble glucose polymers isolated by fractionation of hydrolyzed cornstarch (2).” NCT01170858 ↗ |
| Route | Other | “1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange” NCT00755456 ↗ |