Back to resultsThe Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
Primary Purpose
Kidney Failure, Inflammation
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood Test
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure
Eligibility Criteria
Inclusion Criteria:
- Kidney failure patients undergoing hemodialysis or peritoneal dialysis
Exclusion Criteria:
- Active inflammatory or infectious disease
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hemodialysis group
Peritoneal dialysis
Arm Description
Blood sample taken and sent to laboratory for analysis
Blood sample taken and sent to laboratory for analysis
Outcomes
Primary Outcome Measures
Alpha-Defensin Levels
Alpha-defensin levels will be compared between the two arms
Secondary Outcome Measures
Full Information
NCT ID
NCT03845530
First Posted
February 18, 2019
Last Updated
February 18, 2019
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03845530
Brief Title
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
Official Title
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hemodialysis group
Arm Type
Active Comparator
Arm Description
Blood sample taken and sent to laboratory for analysis
Arm Title
Peritoneal dialysis
Arm Type
Active Comparator
Arm Description
Blood sample taken and sent to laboratory for analysis
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood Test
Intervention Description
Blood test taken and sent for laboratory analysis
Primary Outcome Measure Information:
Title
Alpha-Defensin Levels
Description
Alpha-defensin levels will be compared between the two arms
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Kidney failure patients undergoing hemodialysis or peritoneal dialysis
Exclusion Criteria:
Active inflammatory or infectious disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rami Abu Fanne, MD, PhD
Phone
972-50-3573694
Email
ramia@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Abu Fanne, MD, PhD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami Abu Fanne, MD, PhD
Email
ramia@hadassah.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
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