Chronic Kidney DiseasesTUN-CKDDNCT05577650
Prevalence of Chronic Kidney Disease in Tunisian Diabetics
An observational study of Chronic Kidney Diseases and Diabetes Mellitus, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
In Tunisia, diabetes is a serious public health problem, its prevalence reaches 22.9% of people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic kidney disease is the most common and severe complication of diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, Diabetes Type 2
- How many people
- 10,145 participants
- Where
- 1 siteTunisia
- Study dates
- 9 Jan 2023to 12 Feb 2023
- 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 diabetic subjects with at least 3 months of follow-up, before the inclusion date.
Who may be able to join
- Age > 18 years old
- Diabetes Type 1 or Type 2
- Follow-up at the consultation for at least more than 3 months
- Informed consent of the patient
Who cannot join
- Kidney transplant
- Chronic dialysis
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Tunisian Society for Nephrology, Dialysis and Renal Transplantation
Tunis, 1000
About this study
In Tunisia, diabetes is a serious public health problem, its prevalence reaches 22.9% of people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic kidney disease is the most common and severe complication of diabetes. It is both a major cause of end-stage renal disease and a risk factor for mortality and cardiovascular morbidity, thus becoming an additional public health concern. Early diagnosis of diabetic kidney disease makes it possible to manage patients more effectively and in a multidisciplinary way, to delay its progression to chronic renal failure.
Read the detailed description
In Tunisia, little data exist concerning the epidemiology of chronic kidney disease in diabetics. It is then relevant to assess the incidence of chronic kidney disease among the Tunisian diabetic population.
The study is an observational, multicentric, cross-sectional, and national project. 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, or any healthcare providers in charge of diabetic 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, Diabetes Mellitus, Diabetes Type 2
- Keywords
- Chronic Kidney Disease, Diabetes, Survey
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of chronic kidney disease
Frequency of diabetic 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 posted13 Oct 2022
- Study start9 Jan 2023
- Primary completion12 Feb 2023
- Study completion12 Feb 2023
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,145 participants (actual)
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
- Labidi Jannet, 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
- NCT05577650
- Sponsor's protocol ID
- DAC-013-TUNCKDD
- Acronym
- TUN-CKDD
- Status last verified
- May 2023
- First submitted
- 10 Oct 2022
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Kidney Disease in Tunisian Diabetics
- ClinicalTrials.gov ID
- NCT05577650
- Acronym / sponsor ID
- TUN-CKDD / DAC-013-TUNCKDD
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Diabetes Type 2
- Keywords
- Chronic Kidney Disease, Diabetes, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,145 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Tunisian Society for Nephrology, Dialysis and Renal Transplantation
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 13 Oct 2022 (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, diabetes is a serious public health problem, its prevalence reaches 22.9% of people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic kidney disease is the most common and severe complication of diabetes. It is both a major cause of end-stage renal disease and a risk factor for mortality and cardiovascular morbidity, thus becoming an additional public health concern. Early diagnosis of diabetic kidney disease makes it possible to manage patients more effectively and in a multidisciplinary way, to delay its progression to chronic renal failure.
Detailed description
In Tunisia, little data exist concerning the epidemiology of chronic kidney disease in diabetics. It is then relevant to assess the incidence of chronic kidney disease among the Tunisian diabetic population.
The study is an observational, multicentric, cross-sectional, and national project. 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, or any healthcare providers in charge of diabetic 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
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All diabetic subjects with at least 3 months of follow-up, before the inclusion date.
Key inclusion criteria (4 listed)
- Age > 18 years old
- Diabetes Type 1 or Type 2
- Follow-up at the consultation for at least more than 3 months
- Informed consent of the patient
Key exclusion criteria (2 listed)
- Kidney transplant
- Chronic dialysis
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 diabetic 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 10 May 2023.
- FB page of STNDTRLink provided by the sponsor.
- 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.
Labidi Jannet, 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 Diabetes Mellitus, 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 4 inclusion and 2 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 10 May 2023. 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 10 May 2023.