Kidney Disease, ChronicCKD-MBD-HFNCT03307707
New Heart Failure Biomarkers in Early Stage Chronic Kidney Disease-Mineral and Bone Disorder
An observational study of Kidney Disease, Chronic and Heart Failure, run by Pr. Semir Nouira.
Trial summary
the objective of this study is to : -Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker of HF in patients with CKD-MBD. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease, Chronic, Heart Failure
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2015to 30 Dec 2015
- 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: subjects who visited the emmergency departement or the nephrology departement , meeting the criteria inclusion and have given a written consent .
Who may be able to join
- Early CKD stage
- Heart failure
Who cannot join
- Infections
- cancer
- corticoid therapy
- renal replacement therapy
- Advanced CKD stage
About this study
Official title: Heart Failure and Early Stage Chronic Kidney Disease -Mineral Bone Disorder : the Importance of the New Biomarkers
the objective of this study is to :
-Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker of HF in patients with CKD-MBD.
Read the detailed description
The disorders of mineral metabolism and bone disease are common complications in CKD patients and they are associated with increased morbidity and mortality.
Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness contributing to left ventricular hypertrophy and its pathophysiology involves newly discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho.
The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate early in in the advancement of CKD stage to attain levels in CKD stage 5D.
But we still have few knoweledges if these markers can have some drawbacks for predicting CVD in early stage CKD.
- Conditions
- Kidney Disease, Chronic, Heart Failure
- Keywords
- FGF23, klotho, Mineral Bone Disorder
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure
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 |
|---|---|---|
| Heart Failure (HF) | subjects with a Left Ventricular Ejection Fraction (LVEF) <50% or LVEF >50% and E/e'>10. | |
| No Heart Failure (NHF) | subjects with LVEF>50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast Growth Factor 23 (FGF23)
compare the circulating levels of FGF23 (pg/ml) in the two groups .
Measured: completed data base (after 4 months)
Alpha Klotho
compare the circulating levels of klotho (ng/ml) in the two groups .
Measured: completed data base (after 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start15 Jun 2015
- Primary completion30 Sep 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr. Semir Nouira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Lamti Feten, PhD student, Study chair, Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307707
- Sponsor's protocol ID
- CKD-MBD-HF
- Acronym
- CKD-MBD-HF
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure and Early Stage Chronic Kidney Disease -Mineral Bone Disorder : the Importance of the New Biomarkers
- ClinicalTrials.gov ID
- NCT03307707
- Acronym / sponsor ID
- CKD-MBD-HF / CKD-MBD-HF
- Conditions
- Kidney Disease, Chronic, Heart Failure
- Keywords
- FGF23, klotho, Mineral Bone Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Pr. Semir NouiraUniversity, hospital or other
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 12 Oct 2017 (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 objective of this study is to :
-Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker of HF in patients with CKD-MBD.
Detailed description
The disorders of mineral metabolism and bone disease are common complications in CKD patients and they are associated with increased morbidity and mortality.
Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness contributing to left ventricular hypertrophy and its pathophysiology involves newly discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho.
The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate early in in the advancement of CKD stage to attain levels in CKD stage 5D.
But we still have few knoweledges if these markers can have some drawbacks for predicting CVD in early stage CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure (HF) | – | –subjects with a Left Ventricular Ejection Fraction (LVEF) <50% or LVEF >50% and E/e'>10. |
| No Heart Failure (NHF) | – | –subjects with LVEF>50% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects who visited the emmergency departement or the nephrology departement , meeting the criteria inclusion and have given a written consent .
Key inclusion criteria (2 listed)
- Early CKD stage
- Heart failure
Key exclusion criteria (5 listed)
- Infections
- cancer
- corticoid therapy
- renal replacement therapy
- Advanced CKD stage
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
Fibroblast Growth Factor 23 (FGF23)
Time frame: completed data base (after 4 months)
compare the circulating levels of FGF23 (pg/ml) in the two groups .
Alpha Klotho
Time frame: completed data base (after 4 months)
compare the circulating levels of klotho (ng/ml) in the two groups .
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 12 Oct 2017.
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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.
Lamti Feten, PhD student study chair
Research Laboratory (LR12SP18) University of Monastir Tunisia, Tunisia and Research Unit (UR17ES29) Faculty of Pharmacy , Monastir
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, Chronic and Heart Failure, run by Pr. Semir Nouira.
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 2 inclusion and 5 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Fibroblast Growth Factor 23 (FGF23) (time frame: completed data base (after 4 months)). The study lists 2 primary outcomes in all. 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 12 Oct 2017.