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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04086212




Registration number
NCT04086212
Ethics application status
Date submitted
2/09/2019
Date registered
11/09/2019

Titles & IDs
Public title
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
Scientific title
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.
Secondary ID [1] 0 0
IP-001-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease (ESRD) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Icodextrin, xylitol and carnitine solution for peritoneal dialysis
Treatment: Drugs - EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution

Experimental: IXC Peritoneal dialysis solution - IXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution

Active comparator: Icodextrin - Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution


Treatment: Drugs: Icodextrin, xylitol and carnitine solution for peritoneal dialysis
Patients will receive a long dwell exchange for three days.

Treatment: Drugs: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
Patients will receive a long dwell exchange for three days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Net-ultrafiltration
Timepoint [1] 0 0
Changes from baseline value at the end of each product administration period (3 days)
Secondary outcome [1] 0 0
Sodium removal
Timepoint [1] 0 0
Calculated every day for 3 days during each product administration period.
Secondary outcome [2] 0 0
Carnitine plasmatic level
Timepoint [2] 0 0
Every day for 3 days during each product administration and during the wash-out period
Secondary outcome [3] 0 0
Xylitol plasmatic level
Timepoint [3] 0 0
Every day for 3 days during each product administration and during the wash-out period.
Secondary outcome [4] 0 0
Xylitol absorption
Timepoint [4] 0 0
Every day for 3 days during each product administration
Secondary outcome [5] 0 0
Adverse Events
Timepoint [5] 0 0
Through study completion, an average of 21 days.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2023
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Iperboreal Pharma Srl
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mario Bonomini, MD
Address 0 0
Institute of Nephrology, University of Chieti, Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04086212