Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05489120
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2022-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 244}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)', 'timeFrame': '12 month', 'description': 'Maroni formula : (Measurement of urea in urine + (\\[patient weight\\]\\*0.031))\\*6.25'}], 'secondaryOutcomes': [{'measure': 'Protein intake during the 12 months follow-up', 'timeFrame': '1 month, 3 month, 6 month and 9 month', 'description': 'Maroni formula: (Measurement of urea in urine + (\\[patient weight\\]\\*0.031))\\*6.25'}, {'measure': 'Dietary adherence', 'timeFrame': 'baseline, 1 month, 3 month, 6 month and 12 month', 'description': '3-day dietary record correlated to a 24-hour urine collection'}, {'measure': 'Dietary compliance for products under study', 'timeFrame': 'monthly up to 12 months', 'description': 'quantities consumed of FLAVIS products.'}, {'measure': 'Effects of the LPD on BMI', 'timeFrame': 'baseline, 1 month, 3 month, 6 month and 12 month', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Effects of the LPD on weight', 'timeFrame': 'baseline, 1 month, 3 month, 6 month and 12 month', 'description': 'Weight in kg'}, {'measure': 'Effects of the LPD on body composition: water', 'timeFrame': 'baseline, 1 month, 3 month, 6 month and 12 month', 'description': 'Water in litres'}, {'measure': 'Effects of the LPD on body composition: muscles', 'timeFrame': 'baseline, 1 month, 3 month, 6 month and 12 month', 'description': 'Muscles in Kg'}, {'measure': 'Effects of the LPD on body composition: body protein content', 'timeFrame': 'baseline, 1 month, 3 month, 6 month and 12 month', 'description': 'Body protein content in Kg'}, {'measure': 'Effects of the LPD on Blood', 'timeFrame': 'baseline, 1 month, 3 month, 6 month, 9 month and 12 month', 'description': 'Blood Chemistry'}, {'measure': 'Effects of the LPD on Urine', 'timeFrame': 'baseline, 1 month, 3 month, 6 month, 9 month and 12 month', 'description': 'Urine Chemistry'}, {'measure': 'Effects of the LPD on diabetic patient glycemic profile', 'timeFrame': 'Baseline, 6 month and 12 month', 'description': 'Hb1Ac will be measured'}, {'measure': 'Incidence of Adverse Events [Safety of the LPD]', 'timeFrame': '1 month, 3 month, 6 month, 9 month and 12 month', 'description': 'Questioning and a clinical examination, biological analyses review'}, {'measure': 'Incidence of Adverse Events [Safety of the LPD]', 'timeFrame': '3 month, 6 month and 12 month', 'description': '4-points Likert scale'}, {'measure': 'Patient quality of life', 'timeFrame': 'baseline, 3 month, 6 month and 12 month', 'description': 'SF-36 questionnaire score which from 0 to 100'}, {'measure': 'Patient satisfaction with LPD', 'timeFrame': '3 month, 6 month and 12 month', 'description': 'Auto-questionnaire with numerical scales, closed-ended questions and Likert scales'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-protein diet', 'low-protein foods', 'FLAVIS', 'compliance', 'effectiveness', 'safety'], 'conditions': ['Chronic Kidney Disease Stage 3B', 'Chronic Kidney Disease stage4', 'Chronic Kidney Disease Stage 5', 'Chronic Kidney Disease Stage 3A']}, 'descriptionModule': {'briefSummary': 'The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD patient stage 3a-5 (\\<60 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,\n* With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),\n* Above 1g protein/ kg bw (ideal body weight),\n* LPD-naïve patient,\n* Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),\n* Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),\n* Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),\n* Having given their informed written consent regarding its participation to the protocol.\n\nExclusion Criteria:\n\n* Patient for whom dialysis or transplantation is planned/expected within the next 12 months\n* Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),\n* Uncontrolled Diabetes (HbA1C \\>8.5%),\n* Active cancer (including a 5 years remission period),\n* Psychiatric disorders or inability to follow the protocol,\n* Evidence of any active infectious or uncontrolled inflammatory diseases,\n* Inability to provide blood samples (poor venous capital),\n* Inability to perform correct 24-hours urine collection,\n* Any change of the chronic medication within 1 month before screening,\n* Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,\n* Patient with an active implanted medical device\n* Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.\n* Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.'}, 'identificationModule': {'nctId': 'NCT05489120', 'briefTitle': 'Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Schär AG / SPA'}, 'officialTitle': 'Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study', 'orgStudyIdInfo': {'id': 'EFFLAVIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'COMPARATOR', 'description': 'Follow-up of the CKD patient according to current practice i.e. low protein diet.'}, {'type': 'EXPERIMENTAL', 'label': 'FLAVIS', 'description': 'Follow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS).', 'interventionNames': ['Other: Consumption of FLAVIS']}], 'interventions': [{'name': 'Consumption of FLAVIS', 'type': 'OTHER', 'description': 'Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.', 'armGroupLabels': ['FLAVIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Abbeville', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Morgane Wetzstein', 'role': 'CONTACT', 'email': 'morganewetzstein@yahoo.fr', 'phone': '0364501107', 'phoneExt': '+33'}, {'name': 'Morgane Wetzstein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique sainte isabelle', 'geoPoint': {'lat': 50.10521, 'lon': 1.83547}}, {'city': 'Aix-en-Provence', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Cabinet médical du Dr Magnant', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile Courivaud, Dr', 'role': 'CONTACT', 'email': 'ccourivaud@chu-besancon.fr', 'phone': '0381218585', 'phoneExt': '+33'}, {'name': 'Cecile Courivaud, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Didier Duclous, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jamal Bamould, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Crepin, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Roubiou, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Yannaraki, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Melchior Chabannes, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean Siebel, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mathilde Colladant, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde Prezelin-Reydit, Dr', 'role': 'CONTACT', 'email': 'mathilde.reydit@maisondurein-aurad.fr', 'phone': '0623401667', 'phoneExt': '+33'}, {'name': 'Mathilde prezelin-reydit, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Catherine Lasseur, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charlotte Dumas de la roque, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Celine Nodimar, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ludovic Aubin, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jackaria Muhammad, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maison du Rein', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Manon Charrier, Dr', 'role': 'CONTACT', 'email': 'dr.mcharrier@gbna-sante.fr', 'phone': '0556437017', 'phoneExt': '+33'}, {'name': 'Manon Charrier, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ismail Amal, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arthur Lacapere, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Polyclinique Bordeaux Nord Aquitaine', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Chalon-sur-Saône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ayman Abokasem, Dr', 'role': 'CONTACT', 'email': 'Ayman.Abokasem@ch-chalon71.fr', 'phone': '0385910056', 'phoneExt': '+33'}, {'name': 'Ayman Abokasem, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abdelkader Bemrah, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philippe Dubot, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Quentin Bernard, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH Chalon', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Elisabeth Heng, Pr', 'role': 'CONTACT', 'email': 'aheng@chu-clermontferrand.fr', 'phone': '0473751425', 'phoneExt': '+33'}, {'name': 'Anne-Elisabeth Heng, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alba Atenza, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cyril Garrouste, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Clarisse Greze, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carole Philipponnet, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charlotte Uro-Coste, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Gabriel Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Santélys BFC', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Giorgina PICCOLI, Pr', 'role': 'CONTACT', 'email': 'gpiccoli@ch-lemans.fr', 'phone': '0243432632', 'phoneExt': '+33'}, {'name': 'Giorgina Piccoli, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antioco Fois, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giulia Santagati, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laetitia Koppe, Pr', 'role': 'CONTACT', 'email': 'laetitia.koppe@chu-lyon.fr', 'phone': '0472678715', 'phoneExt': '+33'}, {'name': 'Laetitia Koppe, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Denis Fouque, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Etienne Novel Catin, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christophe Barba, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Solenne Pelletier, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pascaline Alix, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mezaache, Sarah', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospices Civiles de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Hôpital Edouard Heriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amelie Belloi, Dr', 'role': 'CONTACT', 'email': 'abelloi@saintjosephsaintluc.fr', 'phone': '0478618888', 'phoneExt': '+33'}, {'name': 'Amelie Belloi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emmanuel Villar, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cecile Chauvet, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gaelle Wehrlen, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Saint Joseph Saint Luc', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Burtey, Pr', 'role': 'CONTACT', 'email': 'Stephane.BURTEY@ap-hm.fr', 'phone': '0491383042', 'phoneExt': '+33'}, {'name': 'Stephane Burtey, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Romain Vial, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marion Sallee, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital la conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Mâcon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Allyriane Chartier-Dantec, Dr', 'role': 'CONTACT', 'email': 'AlCHARTIER-DANTEC@ch-macon.fr', 'phone': '0385275333', 'phoneExt': '+33'}, {'name': 'Allyriane Chartier-Dantec, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Mâcon', 'geoPoint': {'lat': 46.31407, 'lon': 4.82823}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elsa Ferriere, Dr', 'role': 'CONTACT', 'email': 'elsa.ferriere@aphp.fr', 'phone': '0144495867', 'phoneExt': '+33'}, {'name': 'Elsa Ferriere, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'AURA Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'TERMINATED', 'country': 'France', 'facility': 'Tenon hospital -APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Romans-sur-Isère', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mohamad Al Adib, Dr', 'role': 'CONTACT', 'email': 'm.aladib@hopitaux-drome-nord.fr', 'phone': '0952019494', 'phoneExt': '+33'}, {'name': 'Mohamad Al Adib, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Drôme Nord', 'geoPoint': {'lat': 45.0496, 'lon': 5.06602}}, {'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nans Florens, Pr', 'role': 'CONTACT', 'email': 'nans.florens@chru-strasbourg.fr', 'phone': '0369551325', 'phoneExt': '+33'}, {'name': 'Nans Florens, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laura Braun, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jonas Martzloff, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dorothée Bazin-Kara, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Vienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Abdallah Guerraoui, Dr', 'role': 'CONTACT', 'email': 'abdallah.guerraoui@calydial.org', 'phone': '0474313095', 'phoneExt': '+33'}, {'name': 'Abdallah Guerraoui, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anna Filancia, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Calydial', 'geoPoint': {'lat': 45.52569, 'lon': 4.87484}}, {'city': 'Villefranche-sur-Saône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile Teuma, Dr', 'role': 'CONTACT', 'email': 'CTeuma@hno.fr', 'phone': '0474096855', 'phoneExt': '+33'}, {'name': 'Cecile Teuma, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antonin Bouchet, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kevin Goret-Roycourt, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Nord-Ouest', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'centralContacts': [{'name': 'Vinciane Dumay', 'role': 'CONTACT', 'email': 'v.dumay@slbpharma.com', 'phone': '0756917356', 'phoneExt': '+33'}, {'name': 'Ophélie Flageul', 'role': 'CONTACT', 'email': 'o.flageul@slbpharma.com', 'phone': '0299121962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Laetitia Koppe, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Schär AG / SPA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Slb Pharma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}