protocolSection identificationModule nctId: NCT06281899, orgStudyIdInfo id: 01/2022, briefTitle: Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus, acronym: PRODAPA-CKD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Anemia Working Group Romania, class: OTHER, collaborators name: Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania, collaborators name: Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania, collaborators name: Carol Davila University of Medicine and Pharmacy, descriptionModule briefSummary: This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus, conditionsModule conditions: Chronic Kidney Diseases, conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10 mg Tab, interventions name: Low protein diet, outcomesModule primaryOutcomes measure: Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death, secondaryOutcomes measure: Rate of decline in the estimated Glomerular Filtration Rate, secondaryOutcomes measure: Variation of albuminuria, secondaryOutcomes measure: Variation of HbA1C, secondaryOutcomes measure: Variation of serum cholesterol levels, secondaryOutcomes measure: Variation of serum bicarbonate levels, secondaryOutcomes measure: Variation of serum potassium levels, secondaryOutcomes measure: Variation of serum sodium levels, secondaryOutcomes measure: Variation of hemoglobin levels, secondaryOutcomes measure: Variation of hematocrit levels, secondaryOutcomes measure: All cause hospitalizations, secondaryOutcomes measure: Variation in body weight, secondaryOutcomes measure: Variation in BMI, secondaryOutcomes measure: Variation in handgrip strength, secondaryOutcomes measure: Variation in serum albumin levels, secondaryOutcomes measure: Variation in CRP levels, secondaryOutcomes measure: Changes in the quality of life, otherOutcomes measure: Compliance to the protein intake, otherOutcomes measure: Compliance to the energy intake, otherOutcomes measure: Compliance to carbohydrate intake, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Carol Davila University of Medicine and Pharmacy Bucharest, status: RECRUITING, city: Bucharest, country: Romania, contacts name: Liliana Garneata, Assoc Prof, role: CONTACT, phone: +40722619358, email: lilianagarna@yahoo.com, contacts name: Elena Cuiban, MD, role: CONTACT, phone: +40748975315, email: elenacuiban@yahoo.com, geoPoint lat: 44.43225, lon: 26.10626, hasResults: False