NCT03845530

Brief Summary

The aim of this study is to determine the levels of alpha-defensin throughout the hemodialysis course compared to the levels at the end of a course of peritoneal dialysis, as a reflection of the inflammatory burden.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

February 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 18, 2019

Last Update Submit

February 18, 2019

Conditions

Kidney FailureInflammation

Outcome Measures

Primary Outcomes (1)

  • Alpha-Defensin Levels

    Alpha-defensin levels will be compared between the two arms

    One year

Study Arms (2)

Hemodialysis group

ACTIVE COMPARATOR

Blood sample taken and sent to laboratory for analysis

Diagnostic Test: Blood Test

Peritoneal dialysis

ACTIVE COMPARATOR

Blood sample taken and sent to laboratory for analysis

Diagnostic Test: Blood Test

Interventions

Blood TestDIAGNOSTIC_TEST

Blood test taken and sent for laboratory analysis

Hemodialysis groupPeritoneal dialysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney failure patients undergoing hemodialysis or peritoneal dialysis

You may not qualify if:

  • Active inflammatory or infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Renal InsufficiencyInflammation

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Rami Abu Fanne, MD, PhD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rami Abu Fanne, MD, PhD

CONTACT

972-50-3573694ramia@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 19, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)