Kidney FailureNCT03845530
The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
A study testing Blood Test in people with Kidney Failure and Inflammation, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure, Inflammation
- What is being tested?
- Blood Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney failure patients undergoing hemodialysis or peritoneal dialysis
Who cannot join
- Active inflammatory or infectious disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Rami Abu Fanne, MD, PhD, ramia@hadassah.org.il
About this study
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.
- Conditions
- Kidney Failure, Inflammation
- Being tested
- Blood Test
- Medical subject headings
- Renal Insufficiency, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TestDiagnostic test
Blood test taken and sent for laboratory analysis
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis group | Active comparator | Blood sample taken and sent to laboratory for analysis Receives: Diagnostic Test: Blood Test |
| Peritoneal dialysis | Active comparator | Blood sample taken and sent to laboratory for analysis Receives: Diagnostic Test: Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha-Defensin Levels
Alpha-defensin levels will be compared between the two arms
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study startMar 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rami Abu Fanne, MD, PhD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845530
- Sponsor's protocol ID
- HYMC-123-18
- Status last verified
- Feb 2019
- First submitted
- 18 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
- ClinicalTrials.gov ID
- NCT03845530
- Acronym / sponsor ID
- HYMC-123-18
- Conditions
- Kidney Failure, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis group | Active comparator | Diagnostic Test: Blood TestBlood sample taken and sent to laboratory for analysis |
| Peritoneal dialysis | Active comparator | Diagnostic Test: Blood TestBlood sample taken and sent to laboratory for analysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney failure patients undergoing hemodialysis or peritoneal dialysis
Key exclusion criteria (1 listed)
- Active inflammatory or infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TestBlood test taken and sent for laboratory analysis | Diagnostic test | Hemodialysis group, Peritoneal dialysis |
Primary outcome
Alpha-Defensin Levels
Time frame: One year
Alpha-defensin levels will be compared between the two arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rami Abu Fanne, MD, PhD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Test in people with Kidney Failure and Inflammation, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rami Abu Fanne, MD, PhD (972-50-3573694, ramia@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha-Defensin Levels (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.