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Taking people in RomaniaPhase 4

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.

Key facts

Who runs it
Anemia Working Group Romania
Where
Bucharest, RomaniaSee the site
Trial code
Registry title
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Phase 4
People taking part
200 people, planned
Started
1 Jan 2022
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Dapagliflozin 10 mg Tab
  • Low protein diet
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes and chronic kidney disease whose kidney function has been stable. It tests a low protein diet on top of dapagliflozin and other kidney-protecting drugs.

Age
Over 18 years
Sex
All sexes can join.
Disease stage
Chronic kidney disease (eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria >500 mg/g urinary creatinine) with confirmed type 2 diabetes. Kidney function stable for at least 12 weeks before enrollment.
Earlier treatment
Must have taken ACE/ARBs and/or MRAs for at least 3 months. Must not have had SGLT2i before.

Main reasons for not taking part

  • eGFR < 25 ml/min/1.73 m2
  • Poorly controlled blood pressure (mean BP≥145/85 mm Hg)
  • Class IV NYHA heart failure or a recent major heart event (less than 6 months)
  • Active infection (HBV, HCV, HIV), active cancer, or active autoimmune disease
  • Malnutrition, or kidney transplant with a working graft

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Romania

  • Carol Davila University of Medicine and Pharmacy BucharestBucharest, RomaniaContact: Liliana Garneata, Assoc ProfTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • InterventionTreatment being tested

    Patients will receive a plant-based low protein diet (0.6 g proteins/kg ideal body weight per day) associated with Dapagliflozin 10 mg per day

    Treatment: Dapagliflozin 10 mg Tab and Low protein diet

  • ControlExisting treatment, for comparison

    Patients will receive Dapagliflozin 10 mg per day

    Treatment: Dapagliflozin 10 mg Tab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Low protein diet with dapagliflozin for kidney disease in type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 October 2026