NCT04066855

Brief 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.

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
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 21, 2019

Last Update Submit

August 21, 2019

Conditions

Vascular CalcificationChronic Kidney Failure

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    3 months

Study Arms (2)

Chronic Kidney Disease (CKD)

patients diagnosed as CKD

Renal transplant

recipients of renal transplantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all CKD population and recipients of kidney transplant

You may qualify if:

  • Chronic Kidney disease stages 4 and 5
  • Renal transplant recipients

You may not qualify if:

  • Significant co-morbidity: advanced cancer, advanced liver disease, tertiary hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30119645BACKGROUND

MeSH Terms

Conditions

Vascular CalcificationKidney Failure, Chronic

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed FMM Saleh, MSc

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed FMM Saleh, MSc

CONTACT

+201095066331a-faisal-mm@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

December 1, 2019

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share