InflammationNCT01397773
Pentraxin-3 in Chronic Renal Failure
An observational study of Inflammation and Chronic Kidney Disease, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Inflammation, Chronic Kidney Disease
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2010to Jan 2011
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be selected among those who are followed up in our clinic.
Who may be able to join
- To give informed consent
- Hemodialysis or peritoneal dialysis for more than 3 months
- Creatinin clearance less than 30 ml/min for the pre-dialysis group
Who cannot join
- Not to give informed concent
- Active infection within the last 3 months
- Known chronic inflammatory disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, 34390
About this study
Official title: The Role Pentraxin-3 in the Inflammatory Process in Chronic Renal Failure, and the Association With Other Inflammatory Parameters
The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.
Read the detailed description
The investigators planned to involve four group of patients: Hemodialysis, peritoneal dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved in each group. The laboratory parameters to be measured are Pentraxin-3, C-reactive protein (CRP), high sensitive CRP, fibrinogen and interleukin-6. Concomitantly, carotis intima media thickness will be measured in the radiology clinic. Statistical analysis will be carried on by Statistical Package for Social Sciences (SPSS) for Windows 13.0. The variables acting on the inflammatory parameters and the correlation between them and carotis intima media thickness will be studied.
- Conditions
- Inflammation, Chronic Kidney Disease
- Keywords
- Hemodialysis, peritoneal dialysis, chronic kidney disease, inflammation, carotis intima media thickness
- Medical subject headings
- Inflammation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis group | Patients on chronic hemodialysis program | |
| Peritoneal dialysis group | Patients on chronic peritoneal dialysis program | |
| Pre-dialysis group | Patients with chronic kidney disease stage-4 | |
| Control group | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pentraxin-3 level
Pentraxin-3 level will be compared with other inflammatory markers.
Measured: Five months
Secondary outcomes (1)
Carotis intima media thickness
Correlation of Pentraxin-3 and carotis intima media thickness
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397773
- Sponsor's protocol ID
- PTX-HASEKI
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2011
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Pentraxin-3 in the Inflammatory Process in Chronic Renal Failure, and the Association With Other Inflammatory Parameters
- ClinicalTrials.gov ID
- NCT01397773
- Acronym / sponsor ID
- PTX-HASEKI
- Conditions
- Inflammation, Chronic Kidney Disease
- Keywords
- Hemodialysis, peritoneal dialysis, chronic kidney disease, inflammation, carotis intima media thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Jul 2011 (estimated)
- 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 the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.
Detailed description
The investigators planned to involve four group of patients: Hemodialysis, peritoneal dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved in each group. The laboratory parameters to be measured are Pentraxin-3, C-reactive protein (CRP), high sensitive CRP, fibrinogen and interleukin-6. Concomitantly, carotis intima media thickness will be measured in the radiology clinic. Statistical analysis will be carried on by Statistical Package for Social Sciences (SPSS) for Windows 13.0. The variables acting on the inflammatory parameters and the correlation between them and carotis intima media thickness will be studied.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis group | – | –Patients on chronic hemodialysis program |
| Peritoneal dialysis group | – | –Patients on chronic peritoneal dialysis program |
| Pre-dialysis group | – | –Patients with chronic kidney disease stage-4 |
| Control group | – | –Healthy subjects |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be selected among those who are followed up in our clinic.
Key inclusion criteria (3 listed)
- To give informed consent
- Hemodialysis or peritoneal dialysis for more than 3 months
- Creatinin clearance less than 30 ml/min for the pre-dialysis group
Key exclusion criteria (3 listed)
- Not to give informed concent
- Active infection within the last 3 months
- Known chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pentraxin-3 level
Time frame: Five months
Pentraxin-3 level will be compared with other inflammatory markers.
1 secondary outcome
Carotis intima media thickness
Time frame: Five months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
Related trials for Inflammation
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Chronic Kidney Disease, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 2011. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pentraxin-3 level (time frame: Five months). 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 20 Jul 2011.