Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 4:48 AM
Study NCT ID:
NCT03979534
Status:
UNKNOWN
Last Update Posted:
2022-03-09
First Post:
2019-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018753', 'term': 'Diet, Protein-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-04-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2019-06-03', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the multiple-choice diet program', 'timeFrame': '4 years', 'description': 'Percentage of patients who drop-out of the multiple choice diet program'}], 'secondaryOutcomes': [{'measure': 'Kidney survival', 'timeFrame': '4 years', 'description': 'The "kidney survival" from the beginning of the diet to the start of renal replacement therapy'}, {'measure': 'Patient survival', 'timeFrame': '4 years', 'description': 'The patient survival compared to reference data (from the Réseau Epidemiologie, Information, Néphrologie) and international registers.'}, {'measure': 'Cost of the treatment', 'timeFrame': '4 years', 'description': 'Cost of the treatment, including diet, renal replacement therapy and pharmacological interventions.'}, {'measure': 'Patients included in a transplantation program', 'timeFrame': '4 years', 'description': 'Percentage of patients without contraindications enrolled on the pre-emptive kidney transplant list.'}, {'measure': 'Patients included in a home dialysis program', 'timeFrame': '4 years', 'description': 'Percentage of patients without contraindications who started a home dialysis treatment'}, {'measure': 'Patients included in an incremental dialysis program.', 'timeFrame': '4 years', 'description': 'Percentage of patients without contraindications who started dialysis with an incremental schedule.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-protein diet', 'pre-dialysis', 'chronic kidney disease', 'nutritional care', 'start of dialysis', 'incremental dialysis'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). Protein restriction is a valuable tool for stabilizing chronic kidney disease (CKD) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. This study is aimed at identifying implementation strategies for nutritional management of advanced CKD.', 'detailedDescription': 'The recent paradigm on dialysis start suggests that an intention to defer policy should be preferred to beginning dialysis early ("the earliest the best" strategy). This strategy is further supported by the consideration that patient profiles are changing with the increasing proportion of older and higher comorbidity patients. In high comorbidity patients, survival is not necessarily improved by dialysis.\n\nNutritional care, adapted to each patient\'s needs and preferences, could in part answer these demands. Indeed, renal function has a strict correlation with dietary patterns. Low protein diets may have two favourable effects: 1) slowing down kidney function decline and 2) delaying the need of replacement therapy (metabolic stabilizing). In dialysis, the nutritional state is the most important survival indicator, and nutritional follow-up should allow starting dialysis in a good nutritional status.\n\nThe study proposed here is an implementation study with a principal aim to improve the use of low protein diets in the clinical setting, by offering a multiple choice approach and by adapting the diets to the patients\' needs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients followed on the unit for advanced CKD, with Kidney disease stage 4-5 or stage 3 with fast progression and without contraindications.\n\nExclusion Criteria:\n\n* Malnutrition or short life-expectancy\n* Patients aged less than 18 years old\n* Pregnant women,\n* Incapacity to complete the free-consent form,\n* Pateints refusing participation in the study,\n* Patients without healthcare coverage.'}, 'identificationModule': {'nctId': 'NCT03979534', 'acronym': 'ProReRePro', 'briefTitle': 'Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach', 'orgStudyIdInfo': {'id': 'CHM-2016-S8/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet group', 'description': 'Diet follow-up to personalize a low-protein diet for each patient. All patients following a low protein diet one month or more compose the "diet group".', 'interventionNames': ['Other: low protein diet']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients who accepted to take part of the study but refused the low protein diet and patients who discontinued the diet on the first month compose the control group.'}], 'interventions': [{'name': 'low protein diet', 'type': 'OTHER', 'description': 'Patients will be managed with a restricted protein intake (controlled protein diets with a mean target at 0.6 g / kg / day of protein, according to a choice of dietary approaches, adapted to the situation of each patient).', 'armGroupLabels': ['Diet group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christelle Jadeau, PD', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '0 (33) 2 43 43 43 43', 'phoneExt': '37 482'}], 'facility': 'Centre Hospitalier Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'centralContacts': [{'name': 'Christelle Jadeau, PD', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '0 (33) 2 43 43 43 43', 'phoneExt': '37 482'}], 'overallOfficials': [{'name': 'Giorgina Piccoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier le Mans'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}