- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04066855
Sclerostin and Vascular Calcification in CKD and Renal Transplant
Role of Sclerostin in Vascular Calcification in Patients With Chronic Kidney Disease and Renal Transplantation
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ahmed FMM Saleh, MSc
- Phone Number: +201095066331
- Email: a-faisal-mm@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic Kidney disease stages 4 and 5
- Renal transplant recipients
Exclusion Criteria:
- Significant co-morbidity: advanced cancer, advanced liver disease, tertiary hyperparathyroidism
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Chronic Kidney Disease (CKD)
patients diagnosed as CKD
|
Renal transplant
recipients of renal transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
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
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ahmed FMM Saleh, MSc, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sclerostin-Vas-CKD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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