End-Stage Renal DiseasePhase 2NCT00858182
Study of Safety and Efficacy on New Peritoneal Dialysis Solutions
A Phase 2 study testing PD solution for nocturnal exchanges and PD solution for diurnal exchanges in people with End-Stage Renal Disease, run by Iperboreal Pharma Srl.
Trial summary
A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as osmotic agents to partially replace glucose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- PD solution for nocturnal exchanges and PD solution for diurnal exchanges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jan 2013
- 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 treated for at least three month with CAPD, as stated by the medical staff of the center;
- CAPD treatment with 2.27% of glucose solution for the nocturnal exchange;
- Stable clinical condition within four weeks before screening period, certified by medical/surgical history, physical examination and laboratory exploration;
- Hemoglobin level ≥9g/dL;
- Residual diuresis ≤800mL;
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- Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
- Stable peritoneal permeability, as confirmed by a PET between 0.50 and 0.81 during previous three months and at day 0 of the screening period;
- Total urea Kt/V >1.5 per week at a control during previous three months and at day 0 of the screening period and/or minimal total creatinine clearance of 45 liter/week at a control during previous three months and at day 0 of the screening period; 1- To understand and sign an informed consent form.
- For patients who will be included in Group B, the following criteria must be fulfilled too:
- Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
- Be treated with 2 or 3 diurnal exchange bag solutions (solution bags with 1.36% or 2.27% glucose) and one nocturnal exchange bag solution (Extraneal)
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 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;
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- 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 assessment of study parameters, especially if the life expectation is less then one year;
- Participation in another clinical study within the past month;
- Known or supposed allergic reactions to L-carnitine or xylitol.
About this study
Official title: Evaluation of a New Peritoneal Dialysis Solutions Containing Glucose, Xylitol and L-carnitine Compared to Standard PD Solutions in End-stage Renal Disease (ESRD) Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as osmotic agents to partially replace glucose.
- Conditions
- End-Stage Renal Disease
- Being tested
- PD solution for nocturnal exchanges, PD solution for diurnal exchanges
- Keywords
- L-Carnitine, Xylitol, Peritoneal Dialysis
- 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.
PD solution for nocturnal exchangesDrug
Instillation of a PD solution containing xylitol (1.5%), L-carnitine (0.1%) and glucose (0.5%) for the nocturnal exchange in CAPD treated patients. PD solutions are instilled for 4 weeks.
PD solution for diurnal exchangesDrug
Instillation of a PD solution containing xylitol (0.6%), L-carnitine (0.1%) and glucose (0.5%) for the diurnal exchanges in CAPD treated patients. PD solutions are instilled for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: PD solution for nocturnal exchanges |
| Group B | Experimental | Not described Receives: Drug: PD solution for diurnal exchanges |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess ultrafiltration efficacy of PD solutions containing L-Carnitine and Xylitol
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Cristina Capusa, PhD, Study director, "Dr Carol Davila" University Hospital of Nephrology, RomaniaGabriel Mircescu, PhD, Study chair, "Dr Carol Davila" University Hospital of Nephrology, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858182
- Sponsor's protocol ID
- IP-001-07
- Status last verified
- Mar 2013
- First submitted
- 6 Mar 2009
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Peritoneal Dialysis Solutions Containing Glucose, Xylitol and L-carnitine Compared to Standard PD Solutions in End-stage Renal Disease (ESRD) Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
- ClinicalTrials.gov ID
- NCT00858182
- Acronym / sponsor ID
- IP-001-07
- Conditions
- End-Stage Renal Disease
- Keywords
- L-Carnitine, Xylitol, Peritoneal Dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iperboreal Pharma SrlIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 9 Mar 2009 (estimated)
- 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.
A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as osmotic agents to partially replace glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PD solution for nocturnal exchanges |
| Group B | Experimental | Drug: PD solution for diurnal exchanges |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years;
- Diagnosis of ESRD treated for at least three month with CAPD, as stated by the medical staff of the center;
- CAPD treatment with 2.27% of glucose solution for the nocturnal exchange;
- Stable clinical condition within four weeks before screening period, certified by medical/surgical history, physical examination and laboratory exploration;
- Hemoglobin level ≥9g/dL;
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 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 |
|---|---|---|
| PD solution for nocturnal exchangesInstillation of a PD solution containing xylitol (1.5%), L-carnitine (0.1%) and glucose (0.5%) for the nocturnal exchange in CAPD treated patients. PD solutions are instilled for 4 weeks. | Drug | Group A |
| PD solution for diurnal exchangesInstillation of a PD solution containing xylitol (0.6%), L-carnitine (0.1%) and glucose (0.5%) for the diurnal exchanges in CAPD treated patients. PD solutions are instilled for 4 weeks. | Drug | Group B |
Primary outcome
To assess ultrafiltration efficacy of PD solutions containing L-Carnitine and Xylitol
Time frame: 4 weeks
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 26 Jun 2019.
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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.
Cristina Capusa, PhD study director
"Dr Carol Davila" University Hospital of Nephrology, Romania
Gabriel Mircescu, PhD study chair
"Dr Carol Davila" University Hospital of Nephrology, Romania
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD solution for nocturnal exchanges and PD solution for diurnal exchanges in people with End-Stage Renal Disease, 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 12 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: withdrawn, as of the sponsor's last update on 26 Jun 2019. 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?
To assess ultrafiltration efficacy of PD solutions containing L-Carnitine and Xylitol (time frame: 4 weeks). 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 26 Jun 2019.