NCT05854576

Brief 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) and serum calcium, phosphorus, parathyroid hormone (PTH) in patients with ESRD on regular hemodialysis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

April 8, 2023

Last Update Submit

May 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Interventions

AVF

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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),

You may qualify if:

  • 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.

You may not qualify if:

  • patient \<18 years old
  • patient with primary hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31789482BACKGROUND

Study Officials

  • Eman mohammed

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

soad elsayed

CONTACT

Effat Abdel Hady

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
asoad381@gmail.com

Study Record Dates

First Submitted

April 8, 2023

First Posted

May 11, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

May 11, 2023

Record last verified: 2023-05