Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT07074418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
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': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double blind, placebo-controlled, cross over'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-proteinuric effect', 'timeFrame': '20 months', 'description': 'Changes in mean UACR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).\n\nTo show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, SGLT2i exerts a clinically significant anti-proteinuric effect.'}], 'secondaryOutcomes': [{'measure': 'Body weight effect', 'timeFrame': '20 months', 'description': 'Changes in body weight between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo.\n\nTo show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin acutely decreases body weight.'}, {'measure': 'Urinary sodium effect', 'timeFrame': '20 months', 'description': 'To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin:\n\nincreases urinary sodium excretion. Changes in mean UPCR on spot morning urine samples between 2 days running at baseline and 2 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).'}, {'measure': 'Urinary volume effect', 'timeFrame': '20 months', 'description': 'To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin:\n\nincreases urinary volume. Changes in mean 24-hour urinary.'}, {'measure': 'Blood pressure effect', 'timeFrame': '20 months', 'description': 'To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin: decreases ambulatory blood pressure.\n\nChanges in mean ambulatory systolic blood pressure between 3 days running baseline and 3 days running at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).'}, {'measure': 'eGFR effect by good profile', 'timeFrame': '20 months', 'description': 'To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has a good safety profile (no acute kidney injury or hyperkalaemia \\> 5.5 mmol/L or acidosis (serum bicarbonate \\<23 mmol/L)),'}, {'measure': 'eGFR effect by levels', 'timeFrame': '20 months', 'description': 'Changes in eGFR levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).'}, {'measure': 'eGFR effect by serum potassium', 'timeFrame': '20 months', 'description': 'Changes in serum potassium levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).'}, {'measure': 'eGFR effect by serum bicarbonate', 'timeFrame': '20 months', 'description': 'Changes in serum bicarbonate levels between baseline and every week during each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).'}, {'measure': 'eGFR effect by albuminuria', 'timeFrame': '20 months', 'description': 'Changes in mean 24-hour albuminuria between 3 days running urinary collections at baseline and after starting each treatment period (empagliflozin 10 mg/d and matching placebo).'}, {'measure': 'Effect on HbA1c', 'timeFrame': '20 months', 'description': 'To show that in type 2 diabetic patients with eGFR between 10 and 20 ml/min/1.73m2, empagliflozin has no significant effect on HbA1c.\n\nChanges in HbA1C between baseline and at the end of each 6-week treatment period (empagliflozin 10 mg/d and matching placebo).'}, {'measure': 'Magnitude of eGFR by TEAEs', 'timeFrame': '20 months', 'description': 'Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of treatment emergent adverse events (TEAEs).'}, {'measure': 'Magnitude of eGFR by SAEs', 'timeFrame': '20 months', 'description': 'Describe the magnitude of eGFR decrease following empagliflozin or placebo treatments with the description of serious adverse events (SAEs).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Nephrology', 'eGFR'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure. The investigators therefore hypothesize that SGLT2i should still exert a significant natriuretic effect in patients with eGFR below 20 ml/min/1.73m2, and therefore should still decrease proteinuria with a potential renal protective effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetics,\n* age between 18 and 80 years,\n* RAS blockade at maximal tolerated dosage for 1 month,\n* eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2,\n* UACR \\> 300mg/g creatinine and UPCR \\> 500mg/g creatinine,\n* office systolic blood pressure \\> 110 mmHg,\n* stable dosage of antihypertensive drugs and diuretics for 1 month.\n\nExclusion Criteria:\n\n* any medical condition that, in the opinion of the investigator makes the participant not suitable for inclusion,\n* history of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs,\n* participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening,\n* known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product,\n* judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements,\n* no social insurance,\n* unwilling to give informed consent, vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French).'}, 'identificationModule': {'nctId': 'NCT07074418', 'acronym': 'EMPA[10-20]', 'briefTitle': 'Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 - EMPA [10-20]', 'orgStudyIdInfo': {'id': '23-PP-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'empaglifozine 10mg / wash-out / matching placebo', 'interventionNames': ['Drug: Empagliflozin 10 MG then Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'matching placebo / wash-out / empaglifozine 10mg', 'interventionNames': ['Drug: Placebo then Empagliflozin 10 MG']}], 'interventions': [{'name': 'Empagliflozin 10 MG then Placebo', 'type': 'DRUG', 'otherNames': ['EMPAGLIFLOZIN or iSGLT2'], 'description': 'Taking Empagliflozin first', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo then Empagliflozin 10 MG', 'type': 'DRUG', 'otherNames': ['EMPAGLIFLOZIN or iSGLT2'], 'description': 'Taking the Empagliflozin in second', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'country': 'France', 'contacts': [{'name': 'Vincent ESNAULT, MD-PHD', 'role': 'CONTACT', 'email': 'esnault.v@chu-nice.fr', 'phone': '492038800', 'phoneExt': '+33'}], 'facility': 'CHU Nice - Hôpital Pasteur 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Vincent ESNAULT, MD-PHD', 'role': 'CONTACT', 'email': 'esnault.v@chu-nice.fr', 'phone': '492038800', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Vincent ESNAULT, MD-PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NICE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}