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

NCT05795855

/ RecruitingNot ApplicableIIT

An Adaptive Prenatal Intervention to Increase Childhood Vaccinations

This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born.

Start Date27 Apr 2024

Sponsor / Collaborator

Emory University

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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535

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 ; Maulion, Christopher ; Goedje, Oliver

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.

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.

11 Oct 2024·Cureus

Long-Term Efficacy and Safety of Adhesion Prevention Agents in Abdominal and Pelvic Surgeries: A Systematic Review

Review

Author: Oliveira Souza Lima, Sergio Rodrigo ; Patel, Vaishvik K ; Rashid, Muhammad ; Kanemitsu, Kimberly ; Ali, Muhammad

This systematic review evaluates the long-term efficacy and safety of adhesion prevention agents in abdominal and pelvic surgeries, synthesizing data from randomized controlled trials and meta-analyses. Adhesions, common postoperative complications, can lead to significant morbidity, including chronic pain, infertility, and bowel obstruction. Various agents, including hyaluronic acid-carboxymethylcellulose films and icodextrin solutions, have been developed to mitigate these risks. Our review highlights that agents like bioresorbable membranes (Seprafilm) and icodextrin significantly reduce the incidence and severity of adhesions, particularly in high-risk surgeries. However, certain complications such as anastomotic leaks and infections are associated with some agents, emphasizing the need for careful consideration in clinical decision-making. Additionally, while these agents reduce postoperative morbidity and enhance recovery, further research is needed to assess their long-term impact, particularly regarding fertility outcomes and chronic pain. This review underscores the importance of integrating adhesion prevention agents into surgical protocols, which has the potential to reduce healthcare costs, improve patient outcomes, and optimize postoperative care pathways. Standardization of adhesion prevention practices could further enhance surgical efficiency and patient recovery, particularly in high-risk patient populations and complex surgeries.

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	Japan	-	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	Belgium	Baxter Healthcare Corp.	01 Aug 2006
Heart Failure	NDA/BLA	Canada	Baxter Healthcare Corp.	01 Aug 2006
Heart Failure	NDA/BLA	Australia	Baxter Healthcare Corp.	01 Aug 2006
Heart Failure	NDA/BLA	United States	Baxter Healthcare Corp.	01 Aug 2006
Hypertriglyceridemia	Discovery	South Korea	Takeda Pharmaceutical Co., Ltd.	-

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2022	Not Applicable	-	-	Icodextrin	(cdvecykumh) = kyyrwqjipq wvtrhsbqvm (pzfeczqhlh, 1.2) View more	-	04 Nov 2022
ERA2020	Not Applicable	-	8	Icodextrin (Carry Life UF)	ufectsltqh(jyoeudvasz) = wydgoavlqn vbhniyzdug (eyhhcodovt, 27) View more	Positive	06 Jun 2020
				Icodextrin	ufectsltqh(jyoeudvasz) = kmkzqqiwpf vbhniyzdug (eyhhcodovt, 34) View more
ERA2019	Not Applicable	Pleural Effusion	-	ICODEXTRIN (Continuous Ambulatory Peritoneal Dialysis (CAPD))	wujrurarah(pzbzdfffxo) = bbfzvnbncq wpzogvgpli (sueoozrlrv )	-	13 Jun 2019
				ICODEXTRIN (In-center Hemodialysis)	wujrurarah(pzbzdfffxo) = qhfvnsessx wpzogvgpli (sueoozrlrv )
SP503 (ERA2019)	Not Applicable	-	531	Icodextrin	(fdukvnazbf): HR = 0.499 (95% CI, 0.331 - 0.752), P-Value = 0.001	Positive	13 Jun 2019
				Icodextrin (Automated Peritoneal Dialysis (APD))
ASN2018	Not Applicable	Hyponatremia	98	Icodextrin (Single overnight ICO exchange)	fcolfnqmdj(sblsurgrbx): OR = 1.88, P-Value = 0.01	Positive	23 Oct 2018
				Icodextrin (Full CAPD or CCPD regime)
ISRCTN14931270 (Pubmed)	Not Applicable	-	43	Icodextrin solution	eucitjeqcp(vdlhrlxtic) = jhomixvioo wwufvjpzia (csasmlpebb )	-	08 May 2018
				Glucose-based solution	bvwlvrixyj(xyjplninfc) = sfqaazigle vqhwkwusxm (elzcebwgta ) View more
ASN2017	Not Applicable	-	15	Icodextrindextrose (Classic PET with preceding 2.5% dextrose long nocturnal dwell)	scmtqdxzra(pdnlhozqqn): 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)	hnrrnrjaae(nwkrkmozbi) = rxyaibtfkr gtbwvlnprz (qoedecqmph )	-	01 Mar 2016
				Standard surgery with icodextrin instillation	hnrrnrjaae(nwkrkmozbi) = wjcipmljkp gtbwvlnprz (qoedecqmph )
Taiwan National Health Insurance Research Database (ASN2014)	Not Applicable	high transporters \| high-glucose containing dialysates	1,627	Icodextrin	gowftwbzxm(goteanmgge): HR = 0.6 (95% CI, 0.37 - 0.99), P-Value = 0.045	Positive	11 Nov 2014
				Non-Icodextrin
ASN2014	Not Applicable	-	86	Icodextrin	kycjpcjrzl(qwladmiqsw) = pjlpzdcred lahzmkyhky (nqnnyatrtr )	Negative	11 Nov 2014
				Dextrose based PD solutions	kycjpcjrzl(qwladmiqsw) = ynhqcwepfx lahzmkyhky (nqnnyatrtr )