NCT05030480

Brief Summary

Chronic kidney disease (CKD) is defined as persistent abnormalities of kidney structure or function for more than 3 months leading to a sustained reduction in glomerular filtration rate (GFR) and/or to the occurrence of kidney damage markers, such as albuminuria. \[1\] CKD is an emerging global public health problem, having significant morbidity and mortality costs on society. It is considered as an important component of the epidemic of non-communicable diseases in developed, as well as low-income/middle-income countries. \[2\] In the Kingdom of Saudi Arabia, CKD has been established as a major health issue in recent decades due to the growing incidence and prevalence of end stage kidney disease (ESKD) among the Saudi population. The overall prevalence of CKD was 5.7% in 2010. \[3\] In 2017, there were around two million cases of CKD and 3818 deaths due to CKD in Saudi Arabia in 2017. \[4\] A recent study also reported the overall prevalence of CKD stages 3 to 5 was 4.4% among the Saudi population. \[5\] The major consequences of CKD include disease progression and, subsequently, increased risk of cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 11, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

August 20, 2021

Last Update Submit

August 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • PREVALANCE AND REISK FACTORS

    Prevalence of Chronic Kidney Disease and Associated Risk Factors among hypertensive non-diabetic patients

    3 MONTHS

Study Arms (2)

Chronic kidney disease

eGFR values of less than 60 mL/min/1.73 m2

Diagnostic Test: renal functions

Non-Chronic kidney disease

eGFR values more than 60 mL/min/1.73 m2

Diagnostic Test: renal functions

Interventions

renal functionsDIAGNOSTIC_TEST

urea, creatinine, GFR

Chronic kidney diseaseNon-Chronic kidney disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cross-sectional study, enrolled 607 Saudi patients, of both sexes, registered for Ha'il University Medical Polyclinic, Ha'il city, Saudi Arabia, from October 6, 2020 to January 31, 2021. Patients eligible for inclusion in this study included those who were aged 18 years or older and were diagnosed with hypertension.

You may not qualify if:

  • pregnant or breastfeeding females; history of nephrotoxic drugs use and any case with known cause of CKD other than hypertension such as diabetes mellitus, polycystic kidney disease, obstructive uropathy or autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ha'il

Ha'il, 2440, Saudi Arabia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine- Faculty of Medicine

Study Record Dates

First Submitted

August 20, 2021

First Posted

September 1, 2021

Study Start

May 11, 2020

Primary Completion

January 18, 2021

Study Completion

August 18, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations