Chronic Kidney DiseaseNCT01693744
Pseudoexfoliation and Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Corum State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material in an eye structures and many other parts of the body including kidneys and blood vessels. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 358 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2011to Apr 2012
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from nephrology clinic
Who may be able to join
- All patients with chronic kidney disease stage 1-5
Who cannot join
- History of eye trauma or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Pseudoexfoliation and Chronic Kidney Disease
Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material in an eye structures and many other parts of the body including kidneys and blood vessels. As both PEX and chronic kidney disease (CKD) are associated with oxidative stress and endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.
Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients, group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal kidney functions (control group). Demographic properties and the rate of PEX were evaluated and compaired between the groups.
- Conditions
- Chronic Kidney Disease
- Keywords
- Pseudoexfoliation, chronic kidney disease
- Medical subject headings
- 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 |
|---|---|---|
| Dialysis patients | Patients with stage 5 chronic kidney disease undergoing haemodialysis | |
| Chronic kidney disease patients | Stage 1-4 Chronic kidney disease patients | |
| Control group | Patients with normal renal functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalance of pseudoexfoliation in patients with chronic kidney disease
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startOct 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Prospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corum State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Niyaz, Corum State Hospital
- Investigators
- Leyla Niyaz, M.D., Principal investigator, Specialist in Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693744
- Sponsor's protocol ID
- LNiyaz
- Status last verified
- Sep 2012
- First submitted
- 20 Sep 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pseudoexfoliation and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01693744
- Acronym / sponsor ID
- LNiyaz
- Conditions
- Chronic Kidney Disease
- Keywords
- Pseudoexfoliation, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Corum State HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Sep 2012 (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.
Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material in an eye structures and many other parts of the body including kidneys and blood vessels. As both PEX and chronic kidney disease (CKD) are associated with oxidative stress and endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.
Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients, group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal kidney functions (control group). Demographic properties and the rate of PEX were evaluated and compaired between the groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dialysis patients | – | –Patients with stage 5 chronic kidney disease undergoing haemodialysis |
| Chronic kidney disease patients | – | –Stage 1-4 Chronic kidney disease patients |
| Control group | – | –Patients with normal renal functions |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from nephrology clinic
Key inclusion criteria (1 listed)
- All patients with chronic kidney disease stage 1-5
Key exclusion criteria (1 listed)
- History of eye trauma or surgery
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
Prevalance of pseudoexfoliation in patients with chronic kidney disease
Time frame: 7 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 26 Sep 2012.
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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.
Leyla Niyaz, M.D. principal investigator
Specialist in Ophthalmology
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 Chronic Kidney Disease, run by Corum State 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 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: finished, as of the sponsor's last update on 26 Sep 2012. 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?
Prevalance of pseudoexfoliation in patients with chronic kidney disease (time frame: 7 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 26 Sep 2012.