Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06737094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Severity of Cramps in Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009120', 'term': 'Muscle Cramp'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients', 'timeFrame': 'Day 0 - visit of inclusion'}], 'secondaryOutcomes': [{'measure': 'Measure of Severity of cramps', 'timeFrame': 'Day 0 - visit of inclusion', 'description': 'with a scale'}, {'measure': 'Frequency of pain intensity', 'timeFrame': 'Day 0 - visit of inclusion'}, {'measure': 'Identification of potential triggering factors', 'timeFrame': 'Day 0 - visit of inclusion', 'description': 'through a questionnaire triggering factors will be identified'}, {'measure': 'Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)', 'timeFrame': 'Day 0 - visit of inclusion'}, {'measure': 'Identification of potential improving treatment (medicinal or not)', 'timeFrame': 'Day 0 - visit of inclusion', 'description': 'through a questionnaire which identified potential improving treatment'}, {'measure': 'Impact on Quality Of Life through a questionnaire', 'timeFrame': 'Day 0 - visit of inclusion', 'description': 'impact of cramps on their daily life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cramps', 'Chronic Kidney Disease', 'Pain'], 'conditions': ['Cramps', 'Chronic Kidney Disease(CKD)']}, 'descriptionModule': {'briefSummary': 'Cramps are a frequent and severe complication in CKD patients. Their characteristics : triggering factors, associated factors, are not well known. There is no recognized effective treatment. Using a questionnaire, the investigators wish to determine prevalence, severity and associated factors of cramps in our CKD patients. Better knowledge about cramps in CKD patients will allow to better support, and give a practical tool for treatment evaluation.', 'detailedDescription': 'The investigator have elaborated a specific questionnaire for our CKD patient about cramps. This questionnaire concerns only cramps, regardless of the origin. The first question of the questionnaire will allow to evaluate the prevalence of cramps in our population of CKD patients. Every patient will indicate his medical treatment and biological datas. Only patients who will answer " Yes " to the first question will complete the cramp score of gravity questionnaire. This score is composed of 4 items : frequency of crisis, there impact on sleep, there duration and there intesity Patients will also indicate for how long time there have experimented cramps, the muscular zones involved, associated symptoms, triggering factors, and does something can help them for cramps (medicinal or non medicinal).\n\nThe third part concerns there treatment and biological datas. Finally there will complete the QOL-SF12 questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every patient with Chronic Kidney Disease (non dialysis and dialysis patients)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary patients with CKD III to V (GFR\\<60ml/mn/1,72M2), including dialysed patients (hemodialysis or peritoneal dialysis).\n* Non opposed to participate to the research.\n\nExclusion Criteria:\n\n* Transplanted patient with functional graft.'}, 'identificationModule': {'nctId': 'NCT06737094', 'acronym': 'CRAMéREIN', 'briefTitle': 'Prevalence and Severity of Cramps in Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prevalence and Severity of Cramps in Chronic Kidney Disease Patients', 'orgStudyIdInfo': {'id': 'APHP240246'}, 'secondaryIdInfos': [{'id': 'IDRCB-2024-A00304-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Kidney Disease (CKD) Patients', 'description': 'Patients with CKD stade III to V (dialysis and non dialysis)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Marie-Alyette Costa de Beauregard, MD', 'role': 'CONTACT', 'email': 'marie.costadebeauregard@aphp.fr', 'phone': '+ 33 1 42 17 72 03'}], 'facility': 'Hôpital Pitié Salpêtrière Service de néphrologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Marie-Alyette Costa de Beauregard, MD', 'role': 'CONTACT', 'email': 'marie.costadebeauregard@aphp.fr', 'phone': '+ 33 1 42 17 72 03'}, {'name': 'Jean-Jacques Boffa, PU-PH', 'role': 'CONTACT', 'email': 'jean-jacques.boffa@aphp.fr', 'phone': '+33 (0) 1 56 01 60 29'}], 'overallOfficials': [{'name': 'Marie-Alyette Costa de Beauregard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}