Low protein diet with dapagliflozin for kidney disease in type 2 diabetes
Tests a low protein diet in adults with type 2 diabetes and kidney disease.
Plain-language title generated from the registry record
Registry title: Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Key facts
- Where
- Bucharest, RomaniaSee the site
- Phase
- Phase 4
Where in Romania
- Carol Davila University of Medicine and Pharmacy BucharestBucharest, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anemia Working Group Romania
- Trial code
- NCT06281899
- Record updated
- 28 October 2026
- Original description
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 MellitusRead full original descriptionShow less
Effect of the Low PROtein Diet on Top of DAPAgliflozin and RAASi on the Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
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
Inclusion: 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: kidney transplantation with functional graft; 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); eGFR < 25 ml/min/1.73 m2; malnutrition: BMI<18 kg/me, eight loss >10% during the last 6 months, serum albumin <3 g/dL; poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg); ADPKD; feeding inability (anorexia, nausea).