Delving into the Latest Updates on Icodextrin with Synapse

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.

Start Date15 Aug 2024

Sponsor / Collaborator

Peking University First Hospital

NCT06492031

/ RecruitingNot Applicable

Effectiveness and Safety of Icodextrin Peritoneal Dialysis Solution (Extraneal®) for Long Dwell Exchange in Peritoneal Dialysis in Patients With Chronic Renal Failure: a Multicenter, Ambispective Cohort, Observational, Real-world Study

The purpose of this study is to evaluate the effectiveness and safety of icodextrin and glucose peritoneal dialysis (PD) solutions for the long dwell exchange in PD patients with continuous ambulatory peritoneal dialysis (CAPD), and to describe medical resource utilization in patients with PD on icodextrin.

Start Date28 Jun 2024

Sponsor / Collaborator

Baxter Healthcare Ltd

NCT05943470

/ Not yet recruitingPhase 4IIT

The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis

Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients.
However, icodextrin metabolites are known to accumulate to some extent in the body, resulting in less ultrafiltration with long-term icodextrin use comparing with newly use.
Therefore, the investigator hypothesized that a single dose of icodextrin would produce more ultrafiltration volume with the use of icodextrin dialysate on alternate days than with the use of icodextrin dialysate on daily uses.

Start Date01 Aug 2023

Sponsor / Collaborator

Shanghai Renji Hospital

100 Clinical Results associated with Icodextrin

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100 Translational Medicine associated with Icodextrin

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100 Patents (Medical) associated with Icodextrin

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601

Literatures (Medical) associated with Icodextrin

01 Jan 2025·Kidney Medicine

Development of a Novel Intraperitoneal Icodextrin/Dextrose Solution for Enhanced Sodium Removal

Article

Author: Crosbie, Ian ; Testani, Jeffrey M ; Mendoza-Zavala, Genaro H ; Asher, Jennifer L ; Ramos-Mastache, Daniela ; Rao, Veena S ; Borges-Vela, Julian A ; Ivey-Miranda, Juan B ; Revilla-Monsalve, Cristina ; Cigarroa-Lopez, Jose A ; Moreno-Villagomez, Julieta ; Turner, Jeffrey M ; Silva-Rueda, Rogelio I ; McIntyre, Christopher ; Finkelstein, Fredrick ; Cox, Zachary L ; Goedje, Oliver ; Maulion, Christopher

Rationale & ObjectivePeritoneal dialysis (PD) solutions provide both clearance of uremic toxins and sodium and water. An intraperitoneal (IP) solution of icodextrin and glucose designed without the requirement for uremic toxin clearance could provide substantially greater sodium and water removal than PD solutions.Study DesignWe examined varying concentrations of icodextrin and dextrose IP solutions in rats. We evaluated a 30% icodextrin and 10% dextrose IP solution in animals and humans.ParticipantsSmall and large animal models, and humans (N = 10) with kidney failure.Exposure30% icodextrin and 10% dextrose IP solution.OutcomesWe evaluated ultrafiltration (UF), sodium removal, and peritoneal health in animals. We evaluated safety, tolerability, and efficacy in humans.ResultsIn rats, increasing concentrations of icodextrin and dextrose IP solutions, up to 30% icodextrin and 10% dextrose, produced progressively greater UF (P < 0.001). In sheep treated with 30% icodextrin and 10% dextrose, the mean UF was ∼3.5-fold greater (1.77 ± 0.22 L vs 0.47 ± 0.34 L; P = 0.005) and the mean sodium removal was ∼4-fold greater (7.07 ± 0.72 g vs 1.78 ± 1.27 g; P = 0.003) compared with commercially available 7.5% icodextrin PD solution. Long-term exposure of mice (30 days) and sheep (30-45 days) to a 30% icodextrin and 10% dextrose IP solution resulted in no significant structural tissue changes compared with the control 4.25% commercially available PD solution. In humans, a 24-hour dwell of a 30% icodextrin and 10% dextrose IP solution resulted in median net UF of 2,498 mL (IQR, 2,249-2,768), and median sodium removal of 387 mmol (IQR, 372-434 mmol). No serious adverse events occurred.LimitationsThe long-term safety with chronic therapy and the efficacy in patients without kidney failure were not established and require future studies.ConclusionsA 30% icodextrin and 10% dextrose IP solution provides more efficient UF and sodium removal than traditional PD solutions. The promising inhuman safety and efficacy results warrant future investigation as a sodium removal therapy in patients with edematous disorders such as heart failure.Clinical Trial RegistrationNCT05780086.SummaryWe aimed to design a novel intraperitoneal solution designed for optimal sodium and water removal. A sodium-free 30% icodextrin and 10% dextrose intraperitoneal solution was evaluated in animal models and humans to determine the safety and efficacy. A 30% icodextrin and 10% dextrose solution provides more efficient sodium and water removal than traditional peritoneal dialysis solutions. The promising inhuman safety and efficacy results warrant future investigation as a sodium removal therapy in patients with edematous disorders such as heart failure.

01 Dec 2024·Behaviour Research and Therapy

Augmented Depression Therapy for young adults: A mixed methods randomised multiple baseline case series evaluation

Article

Author: Carson, James ; Loades, Maria ; Wright, Kim ; Dunn, Barnaby D ; Dunn, Barnaby D. ; Demetriou, Kalliopi ; Barlow, Gemma

Augmented Depression Therapy (ADepT) is an individual psychotherapy for depression, which has been shown to be effective in the general adult population. A randomised multiple baseline case series evaluated the feasibility, acceptability, and effectiveness of ADepT in young adults (aged 20-24). Eleven depressed young adults were recruited from a UK university wellbeing service to receive ADepT during the COVID-19 pandemic, with outcomes evaluated relative to pre-specified continuation targets. All participants received a minimum adequate treatment dose (>60% target); 89% judged ADepT as acceptable and satisfactory and would recommend it to others (>60% target); only 9% showed reliable deterioration for depression or wellbeing (meeting <30% target); and there were no trial- or treatment-related serious adverse events. Qualitative interviews revealed most participants were satisfied with and experienced benefits from ADepT. At post-treatment, reliable improvement was shown by 33% of participants for depression and 67% of participants for wellbeing (not meeting target of both >60%), with medium effect size improvements for depression (g = 0.78) and large effect size improvement for wellbeing (g = 0.93; not meeting target of both >0.80). ADepT is feasible, acceptable, and safe in young adults but may require modification to maximise effectiveness. Further research outside of the COVID-19 pandemic is warranted.

18 Nov 2024·Einstein (São Paulo)

Icodextrin versus Glucose 2.5% on markers of hypervolemia and survival of patients undergoing automated peritoneal dialysis with an unplanned start: a randomized controlled trial

Article

Author: Alves, Camila Albuquerque ; Mendes, Marcela Lara ; Ponce, Daniela ; Dias, Dayana Bitencourt ; Banin, Vanessa Burgugi ; Moraes, Thyago Proença de ; Azevedo, Leonardo Sotello ; Silva, Maryanne Zilli Canedo

OBJECTIVEThe efficacy of icodextrin versus glucose patients undergoing peritoneal dialysis remains unclear. The study was designed to compare the effects of once-daily long-dwell icodextrin versus glucose on markers of hypervolemia and survival among patients with kidney failure undergoing an unplanned initiation of automated peritoneal dialysis.METHODSThis was a randomized, non-blinded, and prospective controlled study. Prevalent and stable patients undergoing automated peritoneal dialysis with a recent peritoneal equilibration test showing a dialysate/plasma creatinine of >0.50 were randomized to receive either 7.5% icodextrin or 2.5% glucose solution. Patients were evaluated at baseline (one month after the start of peritoneal dialysis), 3 months, and 6 months after inclusion. The peritoneal dialysis solution was used for at least 3 months, with a follow-up period of 24 months.RESULTSThirty patients were enrolled. There were no baseline differences between the groups. During the study period, patients in the Icodextrin Group showed improvements in the phase angle and ultrafiltration, whereas there were no changes in the Glucose Group. Additionally, extracellular water was significantly lower in the Icodextrin Group at the end of the study than at baseline. No statistical differences between the two groups were observed in urine volume, ultrafiltration, extracellular water, phase angle, renal creatinine clearance, use of diuretics and antihypertensives, or blood pressure. During the 24-month follow-up, the number of events related to overall mortality was seven (Icodextrin Group, n=4; Glucose Group, n=3), with no difference between the groups for this outcome or technique survival.CONCLUSIONIcodextrin significantly improved ultrafiltration, extracellular water, and phase angle at the end of the study compared to baseline in patients on the urgent start of automated peritoneal dialysis.REGISTRY OF CLINICAL TRIALS(www.ctri.nic.in) under the number RBR-97z4wh6.

100 Deals associated with Icodextrin

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KEGG	Wiki	ATC	Drug Bank
D03266	Icodextrin	V07AB	DB00702

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Kidney Diseases	JP	-	29 Nov 2003
Kidney Failure, Chronic	-	Baxter International, Inc.	01 Jan 1994

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	NDA/BLA	BE	Baxter Healthcare Corp.	01 Aug 2006
Heart Failure	NDA/BLA	CA	Baxter Healthcare Corp.	01 Aug 2006
Heart Failure	NDA/BLA	AU	Baxter Healthcare Corp.	01 Aug 2006
Heart Failure	NDA/BLA	US	Baxter Healthcare Corp.	01 Aug 2006
Hypertriglyceridemia	Phase 1	KR	Takeda Pharmaceutical Co., Ltd.	-

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Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2022	Not Applicable	-	-	Icodextrin	(dkxoihakmk) = tnqpibndqz xmjllfestk (ooizysgsgn, 1.2) View more	-	04 Nov 2022
ERA2020	Not Applicable	-	8	Icodextrin (Carry Life UF)	kwvwlwmouw(mmnjufduah) = yzzrhwgveo kzuqbscsov (ncwktesylw, 27) View more	Positive	06 Jun 2020
				Icodextrin	kwvwlwmouw(mmnjufduah) = kdrzlmaqqw kzuqbscsov (ncwktesylw, 34) View more
SP503 (ERA2019)	Not Applicable	-	531	Icodextrin	(jfbbwxmyso): HR = 0.499 (95% CI, 0.331 - 0.752), P-Value = 0.001	Positive	13 Jun 2019
				Icodextrin (Automated Peritoneal Dialysis (APD))
ERA2019	Not Applicable	Pleural Effusion	-	ICODEXTRIN (Continuous Ambulatory Peritoneal Dialysis (CAPD))	dtxyaixvts(lqfmtybvcy) = zqeddllket pcgxzengid (biyhmryidp )	-	13 Jun 2019
				ICODEXTRIN (In-center Hemodialysis)	dtxyaixvts(lqfmtybvcy) = tolyrjdmus pcgxzengid (biyhmryidp )
ASN2018	Not Applicable	Hyponatremia	98	Icodextrin (Single overnight ICO exchange)	adevzbcled(ftutvrslrt): OR = 1.88, P-Value = 0.01	Positive	23 Oct 2018
				Icodextrin (Full CAPD or CCPD regime)
ISRCTN14931270 (Pubmed)	Not Applicable	-	43	Icodextrin solution	enzqiglles(uwvwowfmup) = rdrabjkbna cafidfblsc (kgjdibzpmb )	-	08 May 2018
				Glucose-based solution	xvdghvlskg(upjjsvxseo) = iknbfyhzop yuthiudmmp (zhedbmdsyr ) View more
ASN2017	Not Applicable	-	15	Icodextrindextrose (Classic PET with preceding 2.5% dextrose long nocturnal dwell)	klxaqnvgca(uthjsbaqyq): P-Value = 0.448 View more	Positive	31 Oct 2017
				Uni-PET with preceding 7.5% icodextrin long nocturnal dwell
NCT02318888 (ADEPT, Pubmed \| Colorectal Dis)	Not Applicable	Small intestine obstruction	300	icodextrin (Standard surgery)	uhfrrggjor(mjyiqftcld) = duagjwkdxx wityglvbwy (ipphxypvbi )	-	01 Mar 2016
				Standard surgery with icodextrin instillation	uhfrrggjor(mjyiqftcld) = maoxsxzhvt wityglvbwy (ipphxypvbi )
ASN2014	Not Applicable	-	86	Icodextrin	iupblodbel(fowkgossqg) = tstzzrkyhg ojecacoxwy (fbvlqhympy )	Negative	11 Nov 2014
				Dextrose based PD solutions	iupblodbel(fowkgossqg) = spbriunuwh ojecacoxwy (fbvlqhympy )
Taiwan National Health Insurance Research Database (ASN2014)	Not Applicable	high transporters \| high-glucose containing dialysates	1,627	Icodextrin	rrxdfryzka(vviloickpw): HR = 0.6 (95% CI, 0.37 - 0.99), P-Value = 0.045	Positive	11 Nov 2014
				Non-Icodextrin