The Inflammatory Burden in Hemodialysis vs. Peritoneal Di... | NCT03845530

Studies
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin

NCT03845530

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Feb 19, 2019Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Kidney Failure
Inflammation

Interventions

Blood Test

Countries

Israel

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2019Estimated

Primary Completion Date

Mar 2020Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Feb 18, 2019

First Submission Date that Met QC Criteria

Feb 18, 2019

First Posted Date

Feb 19, 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

Feb 18, 2019

Last Update Posted Date

Feb 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Blood Test	Diagnostic Test	Blood test taken and sent for laboratory analysis	Hemodialysis group Peritoneal dialysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alpha-Defensin Levels	Alpha-defensin levels will be compared between the two arms	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Kidney failure patients undergoing hemodialysis or peritoneal dialysis

Exclusion Criteria:

Active inflammatory or infectious disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rami Abu Fanne, MD, PhD	Contact	972-50-3573694		ramia@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Rami Abu Fanne, MD, PhD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency
D007249	Inflammation

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided