Clinical trial NCT04086212: Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
Official title: Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: End Stage Renal Disease (ESRD)
Lead sponsor: Iperboreal Pharma Srl
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over, controlled, open label.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Net-ultrafiltration
timeFrame: Changes from baseline value at the end of each product administration period (3 days)
Secondary outcomes:
measure: Sodium removal
timeFrame: Calculated every day for 3 days during each product administration period.
measure: Carnitine plasmatic level
timeFrame: Every day for 3 days during each product administration and during the wash-out period
measure: Xylitol plasmatic level
timeFrame: Every day for 3 days during each product administration and during the wash-out period.
measure: Xylitol absorption
timeFrame: Every day for 3 days during each product administration
measure: Adverse Events
timeFrame: Through study completion, an average of 21 days.
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Nephrology, University of Chieti, Italy
name: Mario Bonomini, MD
role: PRINCIPAL_INVESTIGATOR
References: