Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 1:28 AM
Study NCT ID:
NCT04809493
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of interdialytic weight gain during treatment', 'timeFrame': '1, 2, 3 and 4 months after inclusion', 'description': 'change of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.'}], 'secondaryOutcomes': [{'measure': 'Perdialytic tolerance in terms of adverse events occurring', 'timeFrame': '1, 2, 3 and 4 months after inclusion', 'description': 'Perdialytic tolerance in terms of adverse events occurring during all sessions of the study with isonatremic dialysis vs conventional dialysis for an observational period of 2 months each one.'}, {'measure': 'Body composition', 'timeFrame': '1, 2, 3 and 4 months after inclusion', 'description': 'Body composition monthly during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.'}, {'measure': 'Rate of Tolerance', 'timeFrame': '1, 2, 3 and 4 months after inclusion', 'description': 'Rate of Tolerance during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease patient on dialysis (stage 5D)', 'Extracorporeal purification', 'Isonatremic dialysis', 'Sodium'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:\n\n* control of interdialytic weight gain\n* perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study\n* body composition and thirst measured monthly during the 4 months of follow-up.\n* tolerance to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients issued from dialysis units (hospital, clinic, non profit dialysis centers)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Chronic Kidney Disease patient on dialysis (stage 5D)\n* With plasma sodium concentration between 130 and 140 mmol/L\n* Anuric\n* Patient dialysed with dialysis machine allowing isonatremic dialysis treatment\n\nExclusion criteria:\n\n* Patient with plasma sodium concentration below 130 or above 140 mmol/\n* Pacemaker'}, 'identificationModule': {'nctId': 'NCT04809493', 'acronym': 'DISON-IRC', 'briefTitle': 'Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)', 'orgStudyIdInfo': {'id': 'RECHMPL20_0659'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients will be receiving conventional dialysis', 'description': 'Patients will be receiving conventional dialysis treatment followed by isonatremic dialysis treatment during an observational period of 2 months for each treatment', 'interventionNames': ['Procedure: Conventional dialysis treatment', 'Procedure: Isonatremic dialysis treatment']}], 'interventions': [{'name': 'Conventional dialysis treatment', 'type': 'PROCEDURE', 'description': 'Conventional dialysis treatment', 'armGroupLabels': ['patients will be receiving conventional dialysis']}, {'name': 'Isonatremic dialysis treatment', 'type': 'PROCEDURE', 'description': 'Isonatremic dialysis treatment', 'armGroupLabels': ['patients will be receiving conventional dialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34290', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Paul Cristol, Prof', 'role': 'CONTACT', 'email': 'jp-cristol@chu-montpellier.fr', 'phone': '4 67 33 83 15', 'phoneExt': '33'}, {'name': 'Jean-Yves BOSC, MD', 'role': 'CONTACT', 'email': 'j.bosc@aidersante.com', 'phone': '430 781 868', 'phoneExt': '33'}, {'name': 'Farid SAIDANI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hélène LERAY-MORAGUES, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cécile TURC-BARON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas BACHELET, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Franck LEROY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-Sébastien SOUWEINE, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hadia HEBIBI, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Jean-Paul CRISTOL, Prof', 'role': 'CONTACT', 'email': 'jp-cristol@chu-montpellier.fr', 'phone': '+33(0)4 67 33 83 15'}], 'overallOfficials': [{'name': 'Jean-Paul CRISTOL, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH MONTPELLIER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}