End Stage Renal Disease (ESRD)Phase 2NCT04086212
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
A Phase 2 study testing Icodextrin, xylitol and carnitine solution for peritoneal dialysis and EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution in people with End Stage Renal Disease (ESRD), run by Iperboreal Pharma Srl.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- Icodextrin, xylitol and carnitine solution for peritoneal dialysis and EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2019to Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.
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.
Read the 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.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- Icodextrin, xylitol and carnitine solution for peritoneal dialysis, EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icodextrin, xylitol and carnitine solution for peritoneal dialysisDrug
Also called IXC
Patients will receive a long dwell exchange for three days.
EXTRANEAL 7.5G/100Ml Peritoneal Dialysis SolutionDrug
Also called icodextrin
Patients will receive a long dwell exchange for three days.
| Study group | Role | What they receive |
|---|---|---|
| IXC Peritoneal dialysis solution | Experimental | IXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution Receives: Drug: Icodextrin, xylitol and carnitine solution for peritoneal dialysis |
| Icodextrin | Active comparator | Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution Receives: Drug: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes from baseline value at the end of each product administration period (3 days)
Secondary outcomes (5)
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.
Measured: Calculated every day for 3 days during each product administration period.
Carnitine plasmatic level
Carnitine plasmatic level is assessed by chemical analysis of patient's plasma samples.
Measured: Every day for 3 days during each product administration and during the wash-out period
Xylitol plasmatic level
Xylitol plasmatic leve is assessed by chemical analysis of patient's plasma samples.
Measured: Every day for 3 days during each product administration and during the wash-out period.
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.
Measured: Every day for 3 days during each product administration
Adverse Events
Measured: Through study completion, an average of 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start2 Oct 2019
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: The study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over, controlled, open label.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iperboreal Pharma Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Bonomini, MD, Principal investigator, Institute of Nephrology, University of Chieti, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086212
- Sponsor's protocol ID
- IP-001-10
- Status last verified
- Mar 2022
- First submitted
- 2 Sep 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.
- ClinicalTrials.gov ID
- NCT04086212
- Acronym / sponsor ID
- IP-001-10
- Conditions
- End Stage Renal Disease (ESRD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iperboreal Pharma SrlIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross-over, controlled, open label.
| Arm | Type | Receives |
|---|---|---|
| IXC Peritoneal dialysis solution | Experimental | Drug: Icodextrin, xylitol and carnitine solution for peritoneal dialysisIXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution |
| Icodextrin | Active comparator | Drug: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis SolutionExtraneal® (7.5% Icodextrin) Peritoneal dialysis solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Icodextrin, xylitol and carnitine solution for peritoneal dialysisAlso: IXCPatients will receive a long dwell exchange for three days. | Drug | IXC Peritoneal dialysis solution |
| EXTRANEAL 7.5G/100Ml Peritoneal Dialysis SolutionAlso: icodextrinPatients will receive a long dwell exchange for three days. | Drug | Icodextrin |
Primary outcome
Net-ultrafiltration
Time frame: Changes from baseline value at the end of each product administration period (3 days)
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).
5 secondary outcomes
Sodium removal
Time frame: Calculated every day for 3 days during each product administration period.
Carnitine plasmatic level
Time frame: Every day for 3 days during each product administration and during the wash-out period
Xylitol plasmatic level
Time frame: Every day for 3 days during each product administration and during the wash-out period.
Xylitol absorption
Time frame: Every day for 3 days during each product administration
Adverse Events
Time frame: Through study completion, an average of 21 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Bonomini, MD principal investigator
Institute of Nephrology, University of Chieti, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icodextrin, xylitol and carnitine solution for peritoneal dialysis and EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution in people with End Stage Renal Disease (ESRD), run by Iperboreal Pharma Srl.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net-ultrafiltration (time frame: Changes from baseline value at the end of each product administration period (3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.