End Stage Renal DiseasePhase 2NCT04001036

Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

A Phase 2 study testing 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine and 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine in people with End Stage Renal Disease, run by Iperboreal Pharma Srl at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine and 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteItaly
Study dates: 1 Sep 2019to 30 Aug 2022
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

Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
Hemoglobin level ≥ 9g/dL;
Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
To understand and sign an informed consent form.

Who cannot join

History of alcohol or drug abuse in the last six months before selection for the study;
Androgen therapy in the last six months before selection;
Active infections;
History of congestive heart failure stage III and IV New York Heart Association (NYHA);
History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
Clinically relevant cardiac arrhythmia;

Show all 12Show fewer

Clinically relevant abnormalities of functional hepatic tests;
Therapy with L-carnitine or its derivatives in the last three months before selection;
Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
Participation in another clinical study within the past month;
Known allergic reactions to L-carnitine or xylitol.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Department of Nephrology, University of Chieti
Chieti

Other trials in Italy

About this study

Official title: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)

Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.

Conditions: End Stage Renal Disease
Being tested: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine, 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
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.

1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitineDrug
Also called IPX15
One bag for nocturnal (long-dwell) exchange.
0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitineDrug
Also called IPX07
One to three, daily (short-dwell) exchanges

Study groups in NCT04001036
Study group	Role	What they receive
Experimental peritoneal dialysis solution IPX15	Experimental	Patients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription. Receives: Drug: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
Experimental peritoneal dialysis solution IPX07	Experimental	Patients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange. Receives: Drug: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily ultrafiltration volume
Change from baseline
Measured: 28 days

Secondary outcomes (4)

Peritoneal equilibration test
Change from baseline
Measured: 28 days
Weekly total urea Kt/V
Change from baseline
Measured: 28 days
Weekly total creatinine clearance
Change from baseline
Measured: 28 days
Adverse Events
Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201930 Aug 2022

First posted27 Jun 2019
Study start1 Sep 2019
Primary completion30 Aug 2022
Study completion30 Aug 2022

Why it stopped: prematurely interrupted due to significant difficulties in the completion of the sample size defined by the study protocol

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04001036
Sponsor's protocol ID: IP-001-09
Status last verified: Aug 2022
First submitted: 26 Jun 2019
Last updated: 3 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.
PubMed 36472884

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)
ClinicalTrials.gov ID: NCT04001036
Acronym / sponsor ID: IP-001-09
Conditions: End Stage Renal Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: prematurely interrupted due to significant difficulties in the completion of the sample size defined by the study protocol
Enrolment: 11 participants (actual)
Lead sponsor: Iperboreal Pharma SrlIndustry (pharma, biotech, devices)
Study start: 1 Sep 2019 (actual)
Primary completion: 30 Aug 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 27 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental peritoneal dialysis solution IPX15	Experimental	Drug: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitinePatients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription.
Experimental peritoneal dialysis solution IPX07	Experimental	Drug: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitinePatients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
Hemoglobin level ≥ 9g/dL;
Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
To understand and sign an informed consent form.

Key exclusion criteria (12 listed)

History of alcohol or drug abuse in the last six months before selection for the study;
Androgen therapy in the last six months before selection;
Active infections;
History of congestive heart failure stage III and IV New York Heart Association (NYHA);
History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;

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
1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitineAlso: IPX15One bag for nocturnal (long-dwell) exchange.	Drug	Experimental peritoneal dialysis solution IPX15
0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitineAlso: IPX07One to three, daily (short-dwell) exchanges	Drug	Experimental peritoneal dialysis solution IPX07

Primary outcome

Daily ultrafiltration volume
Time frame: 28 days
Change from baseline

4 secondary outcomes

Peritoneal equilibration test
Time frame: 28 days
Weekly total urea Kt/V
Time frame: 28 days
Weekly total creatinine clearance
Time frame: 28 days
Adverse Events
Time frame: 2 months

Results and safety

The study was stopped early (reason given: prematurely interrupted due to significant difficulties in the completion of the sample size defined by the study protocol). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
Derived from this study: PubMed 36472884Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

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, G. D'annunzio University, Chieti, Italy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

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?

Daily ultrafiltration volume (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04001036, which also lists 1 linked publication.

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 3 Mar 2023.