Disorders of Calcium and Bone MetabolismNCT05854576
Markers of Metabolism and Vascular Access in ESRD
An observational study of Disorders of Calcium and Bone Metabolism, run by Soad Elsayed Abu douh.
Trial summary
Aim of the study is to determine the association of markers of mineral metabolism with vascular access out come (maturation, patency of vascular access[AVF,AVG])To verify the relationship between vascular access complication (AVF,AVG) and lower levels of 25(OH)D, higher levels of fibroblast growth factor 23 (FGF23)… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Disorders of Calcium and Bone Metabolism
- What is being tested?
- vascular acess
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Nov 2024
- 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 95 years
- All sexes
- Adult, Older adult
Study population: Despite consistent associations of disordered mineral homeostasis and vascular outcomes in ESRD, few studies have investigated the role of these factors in vascular access outcomes. Thes complex interplay of factors may promote vascular disease through multiple pathways including calcification, endothelial dysfunction, inflammation, activation of the renin-angiotensin-aldosterone system and others are involved(15-16),
Who may be able to join
- patient above the age of 18years old.
- patient on regular hemodialysis with vascular access(AVF,AVG)
- patient with Abnormalities in mineral metabolisms.
- Patient secondary, Tertiary hyperparathyroidism.
Who cannot join
- patient <18 years old
- patient with primary hyperparathyroidism
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Markers of Metabolism and Vascular Acess Outcomes in ESRD in[Single Centre Study]
Aim of the study is to determine the association of markers of mineral metabolism with vascular access out come (maturation, patency of vascular access[AVF,AVG])To verify the relationship between vascular access complication (AVF,AVG) and lower levels of 25(OH)D, higher levels of fibroblast growth factor 23 (FGF23) and serum calcium, phosphorus, parathyroid hormone (PTH) in patients with ESRD on regular hemodialysis.
Read the detailed description
Maintaining patent vascular access is essential for patients with end-stage renal disease (ESRD) on hemodialysis (HD) to prevent life-threatening technique failure. Access complications result in a high burden of hospital admissions, procedures, and costs for patients on HD.
, The pathophysiologic mechanisms underlying vascular access complications are poorly understood. Discovery of potential predictors and subsequent targets for intervention could help design new preventive strategies.Abnormalities in mineral homeostasis are common in patients with ESRD and are associated with numerous adverse outcomes including vascular calcification, inflammation, and mortality.
The Klotho gene encodes for a transmembrane protein, acting as a co-receptor for fibroblast growth factor-23 (FGF23) . The main functions of FGF23 signaling in the kidney are the suppression of vitamin D hormone synthesis, and the suppression of renal tubular phosphate reabsorption .
Impaired excretion of phosphorus due to low kidney function raises fibroblast growth factor 23 (FGF23). FGF23 decreases conversion of 25-hydroxy vitamin D (25(OH)D) to its active 1,25D form, causing calcium to fall and parathyroid hormone(PTH) to rise The development of secondary hyperparathyroidism lead to increased calcium and phosphate release from bones to the blood, causing the deposition of calcium and phosphate in the intima-media layer of arterial wall. and eventuating vascular calcification in these patients. the calcifications might be encountered in the upper extremity arteries in cases with ESRD .Thus, a decrease in the quality of fistula occurs in these tracts utilized frequently at the arteriovenous fistula (AVF) operations. Thes complex interplay of factors may promote vascular disease through multiple pathways including calcification, endothelial dysfunction, inflammation, activation of the renin-angiotensin-aldosterone system and others are involved. Deficiency of 25(OH)D among patients with ESRD is above 80%.1,25D or its analogs are frequently administered to patients with ESRD to overcome the adverse effects. low 25(OH)D associates with mortality in HD patients.
Vitamin D deficiency has been associated with hypertension, insulin resistance, viral and bacterial infection risk, and multiple organ damage due to systemic inflammation.
Despite consistent associations of disordered mineral homeostasis and vascular outcomes in ESRD, few studies have investigated the role of these factors in vascular access out comes
- Conditions
- Disorders of Calcium and Bone Metabolism
- Being tested
- vascular acess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular acessProcedure or surgery
AVF
What is being measured
The primary outcome is the main question the study is designed to answer.
association of markers of mineral metabolism with vascular access out come[maturation and patency of vascular access[AVF,AVG]] .To verify the relationship between vascular access complication (AVF,AVG)
Aim of the study is to determine the association of markers of mineral metabolism with vascular access out come[maturation, and patency] .To verify the relationship between vascular access complication (AVF,AVG) and lower levels of 25(OH)D, higher levels of fibroblast growth factor 23 (FGF23) and serum calcium, phosphorus, parathyroid hormone (PTH) in patients with ESRD on regular hemodialysis.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Nov 2024 (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 Disorders of Calcium and Bone MetabolismStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soad Elsayed Abu douh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soad Elsayed Abu douh, Assiut University
- Investigators
- Eman mohammed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854576
- Sponsor's protocol ID
- mineral metabolism in ESRD
- Status last verified
- May 2023
- First submitted
- 8 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gardezi AI, Karim MS, Rosenberg JE, Scialla JJ, Banerjee T, Powe NR, Shafi T, Parekh RS, Yevzlin AS, Astor BC. Markers of mineral metabolism and vascular access complications: The Choices for Healthy Outcomes in Caring for ESRD (CHOICE) study. Hemodial Int. 2020 Jan;24(1):43-51. doi: 10.1111/hdi.12798. Epub 2019 Dec 1.
PubMed 31789482
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Metabolism and Vascular Acess Outcomes in ESRD in[Single Centre Study]
- ClinicalTrials.gov ID
- NCT05854576
- Acronym / sponsor ID
- mineral metabolism in ESRD
- Conditions
- Disorders of Calcium and Bone Metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soad Elsayed Abu douhUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 11 May 2023 (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.
Aim of the study is to determine the association of markers of mineral metabolism with vascular access out come (maturation, patency of vascular access[AVF,AVG])To verify the relationship between vascular access complication (AVF,AVG) and lower levels of 25(OH)D, higher levels of fibroblast growth factor 23 (FGF23) and serum calcium, phosphorus, parathyroid hormone (PTH) in patients with ESRD on regular hemodialysis.
Detailed description
Maintaining patent vascular access is essential for patients with end-stage renal disease (ESRD) on hemodialysis (HD) to prevent life-threatening technique failure. Access complications result in a high burden of hospital admissions, procedures, and costs for patients on HD.
, The pathophysiologic mechanisms underlying vascular access complications are poorly understood. Discovery of potential predictors and subsequent targets for intervention could help design new preventive strategies.Abnormalities in mineral homeostasis are common in patients with ESRD and are associated with numerous adverse outcomes including vascular calcification, inflammation, and mortality.
The Klotho gene encodes for a transmembrane protein, acting as a co-receptor for fibroblast growth factor-23 (FGF23) . The main functions of FGF23 signaling in the kidney are the suppression of vitamin D hormone synthesis, and the suppression of renal tubular phosphate reabsorption .
Impaired excretion of phosphorus due to low kidney function raises fibroblast growth factor 23 (FGF23). FGF23 decreases conversion of 25-hydroxy vitamin D (25(OH)D) to its active 1,25D form, causing calcium to fall and parathyroid hormone(PTH) to rise The development of secondary hyperparathyroidism lead to increased calcium and phosphate release from bones to the blood, causing the deposition of calcium and phosphate in the intima-media layer of arterial wall. and eventuating vascular calcification in these patients. the calcifications might be encountered in the upper extremity arteries in cases with ESRD .Thus, a decrease in the quality of fistula occurs in these tracts utilized frequently at the arteriovenous fistula (AVF) operations. Thes complex interplay of factors may promote vascular disease through multiple pathways including calcification, endothelial dysfunction, inflammation, activation of the renin-angiotensin-aldosterone system and others are involved. Deficiency of 25(OH)D among patients with ESRD is above 80%.1,25D or its analogs are frequently administered to patients with ESRD to overcome the adverse effects. low 25(OH)D associates with mortality in HD patients.
Vitamin D deficiency has been associated with hypertension, insulin resistance, viral and bacterial infection risk, and multiple organ damage due to systemic inflammation.
Despite consistent associations of disordered mineral homeostasis and vascular outcomes in ESRD, few studies have investigated the role of these factors in vascular access out comes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Despite consistent associations of disordered mineral homeostasis and vascular outcomes in ESRD, few studies have investigated the role of these factors in vascular access outcomes. Thes complex interplay of factors may promote vascular disease through multiple pathways including calcification, endothelial dysfunction, inflammation, activation of the renin-angiotensin-aldosterone system and others are involved(15-16),
Key inclusion criteria (4 listed)
- patient above the age of 18years old.
- patient on regular hemodialysis with vascular access(AVF,AVG)
- patient with Abnormalities in mineral metabolisms.
- Patient secondary, Tertiary hyperparathyroidism.
Key exclusion criteria (2 listed)
- patient <18 years old
- patient with primary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vascular acessAVF | Procedure or surgery | – |
Primary outcome
association of markers of mineral metabolism with vascular access out come[maturation and patency of vascular access[AVF,AVG]] .To verify the relationship between vascular access complication (AVF,AVG)
Time frame: baseline
Aim of the study is to determine the association of markers of mineral metabolism with vascular access out come[maturation, and patency] .To verify the relationship between vascular access complication (AVF,AVG) and lower levels of 25(OH)D, higher levels of fibroblast growth factor 23 (FGF23) and serum calcium, phosphorus, parathyroid hormone (PTH) in patients with ESRD on regular hemodialysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 31789482Gardezi AI, Karim MS, Rosenberg JE, Scialla JJ, Banerjee T, Powe NR, Shafi T, Parekh RS, Yevzlin AS, Astor BC. Markers of mineral metabolism and vascular access complications: The Choices for Healthy Outcomes in Caring for ESRD (CHOICE) study. Hemodial Int. 2020 Jan;24(1):43-51. doi: 10.1111/hdi.12798. Epub 2019 Dec 1.
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.
Eman mohammed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Calcium and Bone Metabolism, run by Soad Elsayed Abu douh.
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 4 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 11 May 2023. 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 soad elsayed (011193711, asoad381@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association of markers of mineral metabolism with vascular access out come[maturation and patency of vascular access[AVF,AVG]] .To verify the relationship between vascular access complication (AVF,AVG) (time frame: baseline). 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 NCT05854576, 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 11 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.