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NCT06281899
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Conditions: Chronic Kidney Diseases, Type 2 Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 200
Sponsor: Anemia Working Group Romania
Location: Carol Davila University of Medicine and Pharmacy Bucharest Bucharest
Summary
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
Eligibility Criteria
Inclusion Criteria:
* age\>18 years old
* confirmed chronic kidney disease (with eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria \>500 mg/g urinary creatinine) and confirmed type 2 Diabetes Mellitus
* stable kidney function for at least 12 weeks before enrollment (defined as decrease in eGFR \< 5 ml/min/1.73 m2/year according to KDIGO 2012 guideline)
* treatment with ACE/ARBs and/or MRAs for at least 3 months
* no previous treatment with SGLT2i
* good nutritional status
* declared and anticipated good compliance with the prescribed diet
* signed informed consent
Exclusion Criteria:
* eGFR \< 25 ml/min/1.73 m2
* poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg)
* class IV NYHA heart failure, recent MACE (less than 6 months)
* relevant comorbid conditions (active infections (HBV, HCV, HIV), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy)
* ADPKD
* kidney transplantation with functional graft
* malnutrition: BMI\10% during the last 6 months, serum albumin \
Source: ClinicalTrials.gov (NCT06281899). StuddyBuddy aggregates publicly available trial information.