NCT06281899RecruitingPhase 4
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 11 Feb 2024
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Anemia Working Group Romania
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT06281899
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 1 Jan 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- kidney transplantation with functional graft
Other illness
- 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)
Lab values
- 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
Other
- poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg)
- ADPKD
- feeding inability (anorexia, nausea)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carol Davila University of Medicine and Pharmacy Bucharest Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.