Chronic Kidney DiseasesCKDNCT05030480
Chronic Kidney Disease Among Hypertensive Patients in Ha'il, Saudi Arabia
An observational study of Chronic Kidney Diseases, run by Zagazig University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- renal functions
- How many people
- 392 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 May 2020to 18 Aug 2021
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients eligible for inclusion in this study included those who were aged 18 years or older and were diagnosed with hypertension
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Chronic Kidney Disease and Associated Risk Factors Among Hypertensive Non-diabetic Patients in Ha'il Region, Saudi Arabia: A Cross-Sectional Study
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.
Read the detailed description
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. Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more, or a diastolic blood pressure (DBP) of 90 mm Hg or more, or taking antihypertensive medication or a positive self-reported history of hypertension (based on a response to the questions "have you ever been told you have high blood pressure" or "a past history of high blood pressure").[13] Exclusion criteria included 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. Among 607 hypertensive patients who underwent health examinations, 175 patients met the exclusion criteria and were removed from the study. We also removed 40 patients from the remaining 432 individuals due to missing data, leaving 392 patients for analysis.Minimum sample required for this study was calculated using the formula: n = z2 [P (1 - P)/(D2)], confidence level at 95 % (z = 1.96), margin of error (D) is set at 0.05, and (P) is the prevalence of hypertension in adult Saudi population set as 25.5 %. (n = 292). Data was collected through an interview questionnaire. The questionnaire included sociodemographic variables (age, sex, height, weight, BMI and smoking habit), hypertension (duration and drugs taken), as well as other chronic comorbidities in addition to previous family history of renal diseases. This is in addition to the laboratory investigations and radiological reports collected from the participants during the interview.
- Conditions
- Chronic Kidney Diseases
- Being tested
- renal functions
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal functionsDiagnostic test
urea, creatinine, GFR
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | eGFR values of less than 60 mL/min/1.73 m2 Receives: Diagnostic Test: renal functions | |
| Non-Chronic kidney disease | eGFR values more than 60 mL/min/1.73 m2 Receives: Diagnostic Test: renal functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
PREVALANCE AND REISK FACTORS
Prevalence of Chronic Kidney Disease and Associated Risk Factors among hypertensive non-diabetic patients
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start11 May 2020
- Primary completion18 Jan 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 392 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed E Ghoniem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030480
- Sponsor's protocol ID
- H-2020-206
- Acronym
- CKD
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Kidney Disease and Associated Risk Factors Among Hypertensive Non-diabetic Patients in Ha'il Region, Saudi Arabia: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05030480
- Acronym / sponsor ID
- CKD / H-2020-206
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 11 May 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 1 Sep 2021 (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.
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.
Detailed description
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. Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more, or a diastolic blood pressure (DBP) of 90 mm Hg or more, or taking antihypertensive medication or a positive self-reported history of hypertension (based on a response to the questions "have you ever been told you have high blood pressure" or "a past history of high blood pressure").[13] Exclusion criteria included 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. Among 607 hypertensive patients who underwent health examinations, 175 patients met the exclusion criteria and were removed from the study. We also removed 40 patients from the remaining 432 individuals due to missing data, leaving 392 patients for analysis.Minimum sample required for this study was calculated using the formula: n = z2 [P (1 - P)/(D2)], confidence level at 95 % (z = 1.96), margin of error (D) is set at 0.05, and (P) is the prevalence of hypertension in adult Saudi population set as 25.5 %. (n = 292). Data was collected through an interview questionnaire. The questionnaire included sociodemographic variables (age, sex, height, weight, BMI and smoking habit), hypertension (duration and drugs taken), as well as other chronic comorbidities in addition to previous family history of renal diseases. This is in addition to the laboratory investigations and radiological reports collected from the participants during the interview.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | Diagnostic Test: renal functionseGFR values of less than 60 mL/min/1.73 m2 |
| Non-Chronic kidney disease | – | Diagnostic Test: renal functionseGFR values more than 60 mL/min/1.73 m2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients eligible for inclusion in this study included those who were aged 18 years or older and were diagnosed with hypertension
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| renal functionsurea, creatinine, GFR | Diagnostic test | Chronic kidney disease, Non-Chronic kidney disease |
Primary outcome
PREVALANCE AND REISK FACTORS
Time frame: 3 MONTHS
Prevalence of Chronic Kidney Disease and Associated Risk Factors among hypertensive non-diabetic patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Zagazig University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PREVALANCE AND REISK FACTORS (time frame: 3 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2021.