Chronic Renal DiseaseNCT01098799
Urotensin II in Chronic Kidney Diseases and Kidney Transplants
An observational study of Chronic Renal Disease, run by Vakif Gureba Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators are planning to study the serum level of Urotensin II in chronic kidney disease patients, kidney transplants, and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Disease
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2010to Jul 2010
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls,CRF patients and kidney transplants aged more than 18
Who may be able to join
- Age more than 18
Who cannot join
- Inability to give a written consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Vakif Gureba Training & Research Hospital
Istanbul, 34100
About this study
Official title: Urotensin II in Chronic Kidney Diseases
The investigators are planning to study the serum level of Urotensin II in chronic kidney disease patients, kidney transplants, and healthy controls.
Read the detailed description
The investigators will determine the urotensin II levels in Chronic kidney disease patients, kidney transplants, and healthy controls.
- Conditions
- Chronic Renal Disease
- Keywords
- Urotensin II,Chronic renal 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 |
|---|---|---|
| Control | Healthy controls | |
| Chronic kidney disease-1 | Chronic kidney disease not taking dialysis treatment | |
| Kidney Transplant | Kidney transplants |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Urotensin II(UII)level
We tried to compare UII level in normal, chronic kidney disease and kidney transplant patients group
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal 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
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vakif Gureba Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Hursitoglu, Vakif Gureba Training and Research Hospital
- Investigators
- Tufan Tukek, MD, Study director, Vakif Gureba Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098799
- Sponsor's protocol ID
- Dahiliye-2-Urotensin
- Status last verified
- Jun 2013
- First submitted
- 2 Apr 2010
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urotensin II in Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT01098799
- Acronym / sponsor ID
- Dahiliye-2-Urotensin
- Conditions
- Chronic Renal Disease
- Keywords
- Urotensin II,Chronic renal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Vakif Gureba Training and Research HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Apr 2010 (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 investigators are planning to study the serum level of Urotensin II in chronic kidney disease patients, kidney transplants, and healthy controls.
Detailed description
The investigators will determine the urotensin II levels in Chronic kidney disease patients, kidney transplants, and healthy controls.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy controls |
| Chronic kidney disease-1 | – | –Chronic kidney disease not taking dialysis treatment |
| Kidney Transplant | – | –Kidney transplants |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls,CRF patients and kidney transplants aged more than 18
Key inclusion criteria (1 listed)
- Age more than 18
Key exclusion criteria (1 listed)
- Inability to give a written consent
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
serum Urotensin II(UII)level
Time frame: at enrollment
We tried to compare UII level in normal, chronic kidney disease and kidney transplant patients group
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 13 Jun 2013.
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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.
Tufan Tukek, MD study director
Vakif Gureba Training & Research Hospital
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 Renal Disease, run by Vakif Gureba 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 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 13 Jun 2013. 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?
serum Urotensin II(UII)level (time frame: at enrollment). 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 13 Jun 2013.