Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine

End Stage Renal Disease (ESRD) Clinical Trial

Official title:

Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04086212
• Other study ID #: IP-001-10
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2022
• Est. completion date: April 2023

Study information

• Verified date: March 2022
• Source: Iperboreal Pharma Srl
• Contact: Arduino Arduini, MD
• Phone: +39.333.6409595
• Email: a.arduini[@]iperboreal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.

Description:

The use of a solution icodextrin, xylitol and carnitine (IXC) as the osmotic agent in dialysate for the long dwell exchange provides sustained ultrafiltration (UF) through colloid osmosis, allowing a consistent reduction in extracellular fluid volume without the expected fall in urine output. The other major advantage of IXC is the reduced exposure and absorption of glucose as the main osmotic agent in PD therapy. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal IXC-based PD solution. Compared to glucose, indeed, carnitine and xylitol are extremely stable naturally occurring compounds, even at temperatures higher than those used to steam-sterilize infusional product. As a consequence, xylitol and carnitine may represent better alternatives than glucose as an osmotic ingredient both from the manufacturing and biocompatibility standpoints. Moreover, xylitol and carnitine have an excellent safety profile and possess distinct systemic actions, which are more favorable than glucose.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for at least 3 months

• A stable clinical condition during the two weeks immediately prior to randomization

• Blood hemoglobin concentration above 8,5 g/100ml

• Has not experienced peritonitis episodes in the last 3 months

• Treated with Extraneal for at least 1 month

• Peritoneal Equilibration Test (PET) performed in the last three months

• Has understood and signed the Informed Consent Form.

Exclusion Criteria:

• History of drug or alcohol abuse in the six months prior to entering the protocol

• Acute infectious condition

• History of severe congestive heart failure and clinically significant arrhythmia

• Malignancy within the past 5 years, including lymphoproliferative disorders

• A medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug

• A clinically relevant under-hydration as judged by the treating physician

• History of L-Carnitine therapy or use in the month before entering the study

• Received any investigational drug in the 3 months before entering the study

• Pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Failure, Chronic

Intervention

Drug:
• Icodextrin, xylitol and carnitine solution for peritoneal dialysis
Patients will receive a long dwell exchange for three days.
• EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
Patients will receive a long dwell exchange for three days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iperboreal Pharma Srl

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net-ultrafiltration	Net Ultrafiltration at 10 hours (duration of long dwell), in mL, is defined as the difference between the weight of drained volume and weight of the effluent (fill volume).	Changes from baseline value at the end of each product administration period (3 days)
Secondary	Sodium removal	Net sodium removal will be calculated as the difference between the total amount of sodium drained at end of long dwell (10 hours) and its measure value in the dialysate at time 0 before the initial infusion. Sodium will determined by the hospital laboratory.	Calculated every day for 3 days during each product administration period.
Secondary	Carnitine plasmatic level	Carnitine plasmatic level is assessed by chemical analysis of patient's plasma samples.	Every day for 3 days during each product administration and during the wash-out period
Secondary	Xylitol plasmatic level	Xylitol plasmatic leve is assessed by chemical analysis of patient's plasma samples.	Every day for 3 days during each product administration and during the wash-out period.
Secondary	Xylitol absorption	Xilitol absorption is determined by calculating the difference (in grams) between the amount of xylitol (measured by lab analysis) in plasma and the amount of xylitol in the patient's dialysis solution administered.	Every day for 3 days during each product administration
Secondary	Adverse Events		Through study completion, an average of 21 days.