NCT03964701

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

May 22, 2019

Last Update Submit

May 24, 2019

Conditions

End Stage Renal DiseaseDialysis

Keywords

childrenrenal failuredialysis

Outcome Measures

Primary Outcomes (1)

  • Change of Peritoneal Equilibration test profile

    Peritoneal Equilibration test

    1 year

Secondary Outcomes (2)

  • Loss of dialysis adequency

    1 year

  • Elevated creatinine

    1 year

Interventions

no interventionOTHER

no interventional study

Eligibility Criteria

Age30 Days - 20 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infants, children and adolescent patients on chronic peritoneal dialysis

You may qualify if:

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

You may not qualify if:

  • Abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st ACADEMIC PEDIATRIC DEPARTMENT

Thessaloniki, 546 36, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peritoneal dialysis PD effluent, blood

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nikoleta Printza

    Aristotle University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikoleta Printza

CONTACT

+302310892466nprintza@gmail.com

Yiannis Ntotis

CONTACT

+302310892466

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof in Paediatric Nephrology

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 28, 2019

Study Start

April 22, 2019

Primary Completion

April 22, 2020

Study Completion

April 22, 2020

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

GR(1)