Vascular CalcificationNCT04066855
Sclerostin and Vascular Calcification in CKD and Renal Transplant
An observational study of Vascular Calcification and Chronic Kidney Failure, run by Ahmed Faisal Mohamed Mohamed Saleh.
Trial summary
the aim of the research is to determine the degree of vascular calcification in chronic kidney disease and post-transplant and whether there is a correlation with the level of serum sclerostin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vascular Calcification, Chronic Kidney Failure
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Sep 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all CKD population and recipients of kidney transplant
Who may be able to join
- Chronic Kidney disease stages 4 and 5
- Renal transplant recipients
Who cannot join
- Significant co-morbidity: advanced cancer, advanced liver disease, tertiary hyperparathyroidism
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Sclerostin in Vascular Calcification in Patients With Chronic Kidney Disease and Renal Transplantation
the aim of the research is to determine the degree of vascular calcification in chronic kidney disease and post-transplant and whether there is a correlation with the level of serum sclerostin.
Read the detailed description
Sclerostin is a 22-kDa glycoprotein encoded by the SOST gene. This glycoprotein is almost exclusively synthesized by osteocytes that are not present near the bone surface but lie in the mineralized cortical and cancellous bone (3).
Sclerostin can exert its inhibitory effects on bone formation by not only inhibiting proliferation, differentiation and function of osteoblast cells but also facilitating their apoptosis(4).
Wnt/β-catenin signalling pathway participates in bone homeostasis and diseases.(5,6) But beyond that, many lines of evidence derived from cell cultures and animal studies indicate that this signalling pathway plays a prominent role in the pathogenesis of atherosclerosis and vascular calcification(VC) (7-10).
Serum sclerostin levels in CKD patients are remarkably higher than those in the normal population, with their values increasing across the CKD stages(4,11).
However; the studies on the association of serum sclerostin with VC and mortality in renal disease patients have yielded conflicting results. Some investigations showed a positive correlation, whereas others suggested no or even negative correlation(12).
VC occurs frequently in CKD patients and its incidence increases across the CKD stages (19). Notably, VC is associated with cardiovascular events (CVEs) and poor prognosis in CKD. It is well recognized that VC occurs in the early years of kidney disease patients recently, even prior to the occurrence of disordered phosphate homeostasis.VC is recognized as a pathological process of osteogenesis initiated by inflammatory factors in vessels(20).
The upregulation of sclerostin in calcified tissues led researchers and clinicians to come up with a hypothesis that sclerostin may be related to the pathogenic mechanism of VC in renal disease patients, leading to a large number of studies to examine the association between sclerostin and VC in CKD patients. However, these studies reported inconsistent results, with some studies showing positive association between sclerostin and VC in CKD patients,(21-24) whereas others showing negative association (25-28) or no association at all(29).
As in CKD patients, kidney transplant recipients' (KTRs') VC strongly predicts cardiovascular events and all-cause mortality over conventional risk factors.
- Conditions
- Vascular Calcification, Chronic Kidney Failure
- Medical subject headings
- Vascular Calcification, Kidney Failure, 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 |
|---|---|---|
| Chronic Kidney Disease (CKD) | patients diagnosed as CKD | |
| Renal transplant | recipients of renal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular calcification
measurement of carotid intima media thickness (CIMT) as an indicator of vascular calcification for all patients included in both groups and comparison of the mean CIMT between the groups
Measured: 3 months
Sclerostin
measurement of serum sclerostin levels for all patients included in both groups and comparison of the mean sclerostin level between the groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study startDec 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular CalcificationStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Faisal Mohamed Mohamed Saleh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Faisal Mohamed Mohamed Saleh, Assiut University
- Investigators
- Ahmed FMM Saleh, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066855
- Sponsor's protocol ID
- Sclerostin-Vas-CKD
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Qin Y, Du L, Luo X. An improvement of carotid intima-media thickness and pulse wave velocity in renal transplant recipients. BMC Med Imaging. 2018 Aug 17;18(1):23. doi: 10.1186/s12880-018-0263-7.
PubMed 30119645
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sclerostin in Vascular Calcification in Patients With Chronic Kidney Disease and Renal Transplantation
- ClinicalTrials.gov ID
- NCT04066855
- Acronym / sponsor ID
- Sclerostin-Vas-CKD
- Conditions
- Vascular Calcification, Chronic Kidney Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ahmed Faisal Mohamed Mohamed SalehUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 26 Aug 2019 (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 aim of the research is to determine the degree of vascular calcification in chronic kidney disease and post-transplant and whether there is a correlation with the level of serum sclerostin.
Detailed description
Sclerostin is a 22-kDa glycoprotein encoded by the SOST gene. This glycoprotein is almost exclusively synthesized by osteocytes that are not present near the bone surface but lie in the mineralized cortical and cancellous bone (3).
Sclerostin can exert its inhibitory effects on bone formation by not only inhibiting proliferation, differentiation and function of osteoblast cells but also facilitating their apoptosis(4).
Wnt/β-catenin signalling pathway participates in bone homeostasis and diseases.(5,6) But beyond that, many lines of evidence derived from cell cultures and animal studies indicate that this signalling pathway plays a prominent role in the pathogenesis of atherosclerosis and vascular calcification(VC) (7-10).
Serum sclerostin levels in CKD patients are remarkably higher than those in the normal population, with their values increasing across the CKD stages(4,11).
However; the studies on the association of serum sclerostin with VC and mortality in renal disease patients have yielded conflicting results. Some investigations showed a positive correlation, whereas others suggested no or even negative correlation(12).
VC occurs frequently in CKD patients and its incidence increases across the CKD stages (19). Notably, VC is associated with cardiovascular events (CVEs) and poor prognosis in CKD. It is well recognized that VC occurs in the early years of kidney disease patients recently, even prior to the occurrence of disordered phosphate homeostasis.VC is recognized as a pathological process of osteogenesis initiated by inflammatory factors in vessels(20).
The upregulation of sclerostin in calcified tissues led researchers and clinicians to come up with a hypothesis that sclerostin may be related to the pathogenic mechanism of VC in renal disease patients, leading to a large number of studies to examine the association between sclerostin and VC in CKD patients. However, these studies reported inconsistent results, with some studies showing positive association between sclerostin and VC in CKD patients,(21-24) whereas others showing negative association (25-28) or no association at all(29).
As in CKD patients, kidney transplant recipients' (KTRs') VC strongly predicts cardiovascular events and all-cause mortality over conventional risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) | – | –patients diagnosed as CKD |
| Renal transplant | – | –recipients of renal transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all CKD population and recipients of kidney transplant
Key inclusion criteria (2 listed)
- Chronic Kidney disease stages 4 and 5
- Renal transplant recipients
Key exclusion criteria (1 listed)
- Significant co-morbidity: advanced cancer, advanced liver disease, tertiary hyperparathyroidism
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
Vascular calcification
Time frame: 3 months
measurement of carotid intima media thickness (CIMT) as an indicator of vascular calcification for all patients included in both groups and comparison of the mean CIMT between the groups
Sclerostin
Time frame: 3 months
measurement of serum sclerostin levels for all patients included in both groups and comparison of the mean sclerostin level between the groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Background: PubMed 30119645Li Z, Qin Y, Du L, Luo X. An improvement of carotid intima-media thickness and pulse wave velocity in renal transplant recipients. BMC Med Imaging. 2018 Aug 17;18(1):23. doi: 10.1186/s12880-018-0263-7.
- Individual participant dataSharing planned: No
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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.
Ahmed FMM Saleh, MSc principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Calcification and Chronic Kidney Failure, run by Ahmed Faisal Mohamed Mohamed Saleh.
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 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: status not confirmed, as of the sponsor's last update on 26 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed FMM Saleh, MSc (+201095066331, a-faisal-mm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular calcification (time frame: 3 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?
On the ClinicalTrials.gov record for NCT04066855, which also lists 1 linked publication.
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 Aug 2019.