End Stage Renal DiseaseNCT03964701
Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics
An observational study of End Stage Renal Disease and Dialysis, run by Baxter (Hellas) Ltd at 1 site in Greece.
Trial summary
Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis Read more about this study
- Who is it for?
- Ages 30 days to 20 years
- Conditions the study is for
- End Stage Renal Disease, Dialysis
- How many people
- 18 participants
- Where
- 1 siteGreece
- Study dates
- 22 Apr 2019to 22 Apr 2020
- Phase
- Observational
- 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 30 days to 20 years
- All sexes
- Child, Adult
Study population: Infants, children and adolescent patients on chronic peritoneal dialysis
Who may be able to join
- Pediatric and adolescent patients on peritoneal dialysis
- Aged:1month -20 years
Who cannot join
- -Abdominal surgery
Trial locations and contacts
1 site in 1 country.
Yiannis Ntotis contact
Greece1 site, 1 recruiting
- Recruiting
1st ACADEMIC PEDIATRIC DEPARTMENT
Thessaloniki, 546 36
Nikoleta Printza
About this study
Official title: Identification of Early Biomarkers of Peritoneal Membrane Dysfunction in Children on Peritoneal Dialysis Using Metabolomics Analysis
Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis
Read the detailed description
Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis. Identification of peritoneal membrane functional status changes over time, at the same patient (cohort study), by metabolomics, aiming in personalized medicine best practice.
Identification of peritoneal membrane functional status changes over time in immature infants' peritoneal membrane.
Identification of early and accurate markers of peritoneal membrane dysfunction when membrane status is possibly reversible that could predict peritoneal patients at risk for future loss of ultrafiltration and dialysis adequacy of small molecules examined today be PET, KT/V and Cr/Cl (when membrane status is not reversible).
Improve PD survival in infants and children.
- Conditions
- End Stage Renal Disease, Dialysis
- Being tested
- no intervention
- Keywords
- children, renal failure, dialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Peritoneal Equilibration test profile
Peritoneal Equilibration test
Measured: 1 year
Secondary outcomes (2)
Loss of dialysis adequency
KT/V
Measured: 1 year
Elevated creatinine
Creatinine Clearence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start22 Apr 2019
- Primary completion22 Apr 2020 (estimated)
- Study completion22 Apr 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxter (Hellas) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Nikoleta Printza, Aristotle University Of Thessaloniki
- Investigators
- Nikoleta Printza, Principal investigator, Aristotle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964701
- Sponsor's protocol ID
- 98550
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Early Biomarkers of Peritoneal Membrane Dysfunction in Children on Peritoneal Dialysis Using Metabolomics Analysis
- ClinicalTrials.gov ID
- NCT03964701
- Acronym / sponsor ID
- 98550
- Conditions
- End Stage Renal Disease, Dialysis
- Keywords
- children, renal failure, dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Baxter (Hellas) LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 22 Apr 2020 (estimated)
- Study completion
- 22 Apr 2020 (estimated)
- First posted
- 28 May 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.
Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis
Detailed description
Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis. Identification of peritoneal membrane functional status changes over time, at the same patient (cohort study), by metabolomics, aiming in personalized medicine best practice.
Identification of peritoneal membrane functional status changes over time in immature infants' peritoneal membrane.
Identification of early and accurate markers of peritoneal membrane dysfunction when membrane status is possibly reversible that could predict peritoneal patients at risk for future loss of ultrafiltration and dialysis adequacy of small molecules examined today be PET, KT/V and Cr/Cl (when membrane status is not reversible).
Improve PD survival in infants and children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Infants, children and adolescent patients on chronic peritoneal dialysis
Key inclusion criteria (2 listed)
- Pediatric and adolescent patients on peritoneal dialysis
- Aged:1month -20 years
Key exclusion criteria (1 listed)
- -Abdominal surgery
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 |
|---|---|---|
| no interventionno interventional study | Other | – |
Primary outcome
Change of Peritoneal Equilibration test profile
Time frame: 1 year
Peritoneal Equilibration test
2 secondary outcomes
Loss of dialysis adequency
Time frame: 1 year
Elevated creatinine
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for End Stage Renal Disease
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
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.
Yiannis Ntotis contact
Nikoleta Printza principal investigator
Aristotle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Dialysis, run by Baxter (Hellas) Ltd at 1 site in Greece.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 May 2019. 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 Greece. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikoleta Printza (+302310892466, nprintza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Peritoneal Equilibration test profile (time frame: 1 year). 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 28 May 2019.