Chronic Kidney DiseasesTUN-CKDHNCT05991089
Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients
An observational study of Chronic Kidney Diseases and Hypertension, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
In Tunisia, high blood pressure (HTN) is a public health problem whose prevalence varies from 28.7% to 34.7%. Hypertension can be both, cause and consequence of chronic kidney disease, and its prevalence is quite high in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension
- How many people
- 11,770 participants
- Where
- 1 siteTunisia
- Study dates
- 8 Jan 2024to 1 Jul 2024
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All confirmed hypertensive patients at enrollment
Who may be able to join
- Confirmed Hypertension
- Follow-up at consultation at least for three months before enrollment date
- Informed consent
Who cannot join
- Hypertension emergency
- Pregnancy
- Kidney transplanted subjects
- Dialysis stage
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Tunisian Society for Nephrology, Dialysis and Renal Transplantation
Tunis, Tunisia, 1000
About this study
Official title: Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients. National Multicentric Cross Section Survey.
In Tunisia, high blood pressure (HTN) is a public health problem whose prevalence varies from 28.7% to 34.7%. Hypertension can be both, cause and consequence of chronic kidney disease, and its prevalence is quite high in this population. It is both a risk factor for mortality and cardiovascular morbidity, but also a major cause of terminal chronic kidney disease becoming an additional public health concern.
Detecting and diagnosing chronic kidney in all hypertensives at an early stage remains a global public health challenge. A well-conducted treatment makes it possible to reach the blood pressure objective but also to reduce the risk of occurrence of a cardiovascular event and to slow the progression of chronic kidney disease.
In Tunisia, few data exists concerning the prevalence of chronic kidney disease in hypertensive subjects, thus limiting the development and elaboration of preventive measures. A national survey will thus be conducted by the "Kidney and Metabolic Diseases" Working Group under the aegis of the Tunisian Society of Nephrology, Dialysis and Kidney Transplantation. The main objective is to estimate the prevalence of chronic kidney disease in hypertensive tunisian patients.
Read the detailed description
This is national multicentric cross-sectional survey. The study will be carried out for one month at medical departments and ambulatory clinics of general physicians, family medicine specialists, endocrinologists, specialists in nutrition and metabolic diseases, nephrologists, internal medicine physicians, cardiologists, all physicians caring for non-diabetic hypertensive patients or any healthcare providers in charge of hypertensive patients.
A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
- Conditions
- Chronic Kidney Diseases, Hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Chronic Kidney Disease
Frequency of hypertensive subjects with chronic kidney disease
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Jan 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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.
- 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
- 11,770 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Tunisian Society for Nephrology, Dialysis and Renal Transplantation
- Responsible party
- Sponsor
- Investigators
- Jannet Labidi, MD, Study chair, Military Hospital of Tunis (Tunis, Tunisia)Amel Harzallah, MD, Principal investigator, University Hospital of Charles Nicolle (Tunis, Tunisia)Awatef Azzabi, MD, Principal investigator, University Hospital of Sahloul (Sousse, Tunisia)Badreddine Ben Kaab, MD, Principal investigator, La Marsa Internal Security Forces Hospital (Tunis, Tunisia)Ikram Mami, MD, Principal investigator, University Hospital of La Rabta (Tunis, Tunisia)Lamia Rais, MD, Principal investigator, University Hospital of La Rabta (Tunis, Tunisia)Maissa Hadji Brahim, MD, Principal investigator, University Hospital of Taher Sfar (Mahdia, Tunisia)Mouna Hammouda, MD, Principal investigator, University Hospital of Fattouma Bourguiba (Monastir, Tunisia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991089
- Sponsor's protocol ID
- DAC-014-TUNCKDH
- Acronym
- TUN-CKDH
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients. National Multicentric Cross Section Survey.
- ClinicalTrials.gov ID
- NCT05991089
- Acronym / sponsor ID
- TUN-CKDH / DAC-014-TUNCKDH
- Conditions
- Chronic Kidney Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,770 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Tunisian Society for Nephrology, Dialysis and Renal Transplantation
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 14 Aug 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.
In Tunisia, high blood pressure (HTN) is a public health problem whose prevalence varies from 28.7% to 34.7%. Hypertension can be both, cause and consequence of chronic kidney disease, and its prevalence is quite high in this population. It is both a risk factor for mortality and cardiovascular morbidity, but also a major cause of terminal chronic kidney disease becoming an additional public health concern.
Detecting and diagnosing chronic kidney in all hypertensives at an early stage remains a global public health challenge. A well-conducted treatment makes it possible to reach the blood pressure objective but also to reduce the risk of occurrence of a cardiovascular event and to slow the progression of chronic kidney disease.
In Tunisia, few data exists concerning the prevalence of chronic kidney disease in hypertensive subjects, thus limiting the development and elaboration of preventive measures. A national survey will thus be conducted by the "Kidney and Metabolic Diseases" Working Group under the aegis of the Tunisian Society of Nephrology, Dialysis and Kidney Transplantation. The main objective is to estimate the prevalence of chronic kidney disease in hypertensive tunisian patients.
Detailed description
This is national multicentric cross-sectional survey. The study will be carried out for one month at medical departments and ambulatory clinics of general physicians, family medicine specialists, endocrinologists, specialists in nutrition and metabolic diseases, nephrologists, internal medicine physicians, cardiologists, all physicians caring for non-diabetic hypertensive patients or any healthcare providers in charge of hypertensive patients.
A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All confirmed hypertensive patients at enrollment
Key inclusion criteria (3 listed)
- Confirmed Hypertension
- Follow-up at consultation at least for three months before enrollment date
- Informed consent
Key exclusion criteria (4 listed)
- Hypertension emergency
- Pregnancy
- Kidney transplanted subjects
- Dialysis stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Chronic Kidney Disease
Time frame: At inclusion
Frequency of hypertensive subjects with chronic kidney disease
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 5 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Jannet Labidi, MD study chair
Military Hospital of Tunis (Tunis, Tunisia)
Amel Harzallah, MD principal investigator
University Hospital of Charles Nicolle (Tunis, Tunisia)
Awatef Azzabi, MD principal investigator
University Hospital of Sahloul (Sousse, Tunisia)
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 and Hypertension, run by Dacima Consulting at 1 site in Tunisia.
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 3 inclusion and 4 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 5 Sep 2024. 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 Tunisia. 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?
Prevalence of Chronic Kidney Disease (time frame: At inclusion). 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 5 Sep 2024.