Chronic Kidney DiseaseNCT01317173
Factors Related to the Progression of Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2008to Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with non-diabetic chronic kidney disease between the ages of 18 and 65 years old.
Who may be able to join
- Non-diabetic chronic kidney disease
Who cannot join
- Presence of DM
- Actively using calcium based phosphorus binder of vitamin D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of FGF23 and Klotho on Progression of Chronic Kidney Disease
Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. It has been recently documented that FGF23 and Klotho are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease progression, FGF 23, Klotho
- 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 |
|---|---|---|
| Progressive disease | Serum creatinin level rise more than 2 times | |
| Non-progressive disease | Serum creatinin level rise less than 2 times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of kidney disease
Doubling of creatinin, requirement of renal replacement therapy
Measured: continuous measurement of kidney functions 3 monthly for two years or until the outcome reached
Secondary outcomes (1)
Evaluation of Ca P metabolism
Determination of Ca-P metabolism disorders.
Measured: 3 monthly for two years or until the outcome reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2008
- Primary completionMay 2011 (estimated)
- Study completionJun 2011 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Education and Research Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317173
- Sponsor's protocol ID
- NEPH001
- Status last verified
- Jan 2011
- First submitted
- 16 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of FGF23 and Klotho on Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01317173
- Acronym / sponsor ID
- NEPH001
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease progression, FGF 23, Klotho
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara Education and Research HospitalOther government
- Study start
- Mar 2008
- Primary completion
- May 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 17 Mar 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.
Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. It has been recently documented that FGF23 and Klotho are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive disease | – | –Serum creatinin level rise more than 2 times |
| Non-progressive disease | – | –Serum creatinin level rise less than 2 times |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non-diabetic chronic kidney disease between the ages of 18 and 65 years old.
Key inclusion criteria (1 listed)
- Non-diabetic chronic kidney disease
Key exclusion criteria (2 listed)
- Presence of DM
- Actively using calcium based phosphorus binder of vitamin D
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
Progression of kidney disease
Time frame: continuous measurement of kidney functions 3 monthly for two years or until the outcome reached
Doubling of creatinin, requirement of renal replacement therapy
1 secondary outcome
Evaluation of Ca P metabolism
Time frame: 3 monthly for two years or until the outcome reached
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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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.
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 Chronic Kidney Disease, run by Ankara Education 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 2 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 17 Mar 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?
Results are not available in the source record.
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?
Progression of kidney disease (time frame: continuous measurement of kidney functions 3 monthly for two years or until the outcome reached). 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 17 Mar 2011.