Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-30 @ 12:01 AM
Study NCT ID:
NCT05577650
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2022-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Chronic Kidney Disease in Tunisian Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of chronic kidney disease', 'timeFrame': 'At inclusion', 'description': 'Frequency of diabetic subjects with chronic kidney disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Diabetes', 'Survey'], 'conditions': ['Chronic Kidney Diseases', 'Diabetes Mellitus', 'Diabetes Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.facebook.com/STNDTR/', 'label': 'FB page of STNDTR'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nA 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All diabetic subjects with at least 3 months of follow-up, before the inclusion date.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Diabetes Type 1 or Type 2\n* Follow-up at the consultation for at least more than 3 months\n* Informed consent of the patient\n\nExclusion Criteria:\n\n* Kidney transplant\n* Chronic dialysis'}, 'identificationModule': {'nctId': 'NCT05577650', 'acronym': 'TUN-CKDD', 'briefTitle': 'Prevalence of Chronic Kidney Disease in Tunisian Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Dacima Consulting'}, 'officialTitle': 'Prevalence of Chronic Kidney Disease in Tunisian Diabetics', 'orgStudyIdInfo': {'id': 'DAC-013-TUNCKDD'}}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Tunisian Society for Nephrology, Dialysis and Renal Transplantation', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Labidi Jannet, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Military Hospital of Tunis (Tunis, Tunisia)'}, {'name': 'Amel Harzallah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Charles Nicolle (Tunis, Tunisia)'}, {'name': 'Awatef Azzabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Sahloul (Sousse, Tunisia)'}, {'name': 'Badreddine Ben Kaab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Marsa Internal Security Forces Hospital (Tunis, Tunisia)'}, {'name': 'Ikram Mami, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of La Rabta (Tunis, Tunisia)'}, {'name': 'Lamia Rais, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of La Rabta (Tunis, Tunisia)'}, {'name': 'Maissa Hadji Brahim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Taher Sfar (Mahdia, Tunisia)'}, {'name': 'Mouna Hammouda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Fattouma Bourguiba (Monastir, Tunisia)'}, {'name': 'Sahar Agrebi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Charles Nicolle (Tunis, Tunisia)'}, {'name': 'Seifeddine Azaiez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Private Clinic (Ben Arous, Tunisia)'}, {'name': 'Soumaya Chargui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Charles Nicolle (Tunis, Tunisia)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dacima Consulting', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tunisian Society for Nephrology, Dialysis and Renal Transplantation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}