Peritoneal Membrane Dysfunction in Peritoneal Dialysis Us... | NCT03964701

Studies
Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics

NCT03964701

Sponsor

Baxter (Hellas) Ltd

Status

Unknown status

Last Update Posted

May 28, 2019Actual

Enrollment

18Estimated

Phase

Not provided

Conditions

End Stage Renal Disease
Dialysis

Interventions

no intervention

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2019Actual

Primary Completion Date

Apr 22, 2020Estimated

Completion Date

Apr 22, 2020Estimated

First Submitted Date

May 22, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2019

Last Update Posted Date

May 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nikoleta Printza, Associate Prof in Paediatric Nephrology, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Baxter (Hellas) LtdINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no interventional study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Peritoneal Equilibration test profile	Peritoneal Equilibration test	1 year

Secondary Outcomes

Measure	Description	Time Frame
Loss of dialysis adequency	KT/V	1 year
Elevated creatinine	Creatinine Clearence	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric and adolescent patients on peritoneal dialysis
Aged:1month -20 years

Exclusion Criteria:

-Abdominal surgery

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Days

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Infants, children and adolescent patients on chronic peritoneal dialysis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nikoleta Printza	Contact	+302310892466		nprintza@gmail.com
Yiannis Ntotis	Contact	+302310892466

Overall Officials

Name	Affiliation	Role
Nikoleta Printza	Aristotle University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st ACADEMIC PEDIATRIC DEPARTMENT	Recruiting	Thessaloniki		546 36	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided