Chronic Kidney DiseasesPhase 4PRODAPA-CKDNCT06281899
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Dapagliflozin 10 mg Tab and Low protein diet in people with Chronic Kidney Diseases and Type 2 Diabetes Mellitus, run by Anemia Working Group Romania at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Type 2 Diabetes Mellitus
- What is being tested?
- Dapagliflozin 10 mg Tab and Low protein diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2022to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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<18 kg/me, eight loss >10% during the last 6 months, serum albumin <3 g/dL
- feeding inability (anorexia, nausea)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest
Liliana Garneata, Assoc Prof, +40722619358, lilianagarna@yahoo.com
Elena Cuiban, MD, +40748975315, elenacuiban@yahoo.com
About this study
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
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
Read the detailed description
The KDIGO Diabetes in CKD Guideline (2020) recommends the use of SGLT2i (level 1A) and suggests (level 2C) the prescription of plant protein-based low-protein diet in patients with chronic kidney disease (CKD) and diabetes mellitus (DM). Both interventions have shown synergistic nephroprotective effects, slowing the progression of chronic kidney disease by reducing glomerular hyperfiltration and proteinuria, thus resulting the hypothesis that by combining these two interventions it could be possible to achieve a superior control over the progression of diabetic kidney disease.
The nutritional intervention will consist in a mild protein restriction (0.6 g/kg dry ideal body weight) and a total recommended energy intake of 30-35 kcal/kg of ideal dry body weight per day in all patients. The protein intake will be checked through the food diary and calculated based on urea from 24 hours urine collection.
The efficacy and safety parameters will be evaluated during follow-up visits at month 1,2,3,6,12 and 18.
- Conditions
- Chronic Kidney Diseases, Type 2 Diabetes Mellitus
- Being tested
- Dapagliflozin 10 mg Tab, Low protein diet
- Keywords
- chronic kidney disease, low protein diet, nutrition therapy
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mg TabDrug
Dapagliflozin 10 mg once daily
Low protein dietBehavioural
Plant based low protein diet (0.6 g/kg IBW)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Drug: Dapagliflozin 10 mg Tab; Behavioral: Low protein diet |
| Control | Active comparator | Patients will receive Dapagliflozin 10 mg per day Receives: Drug: Dapagliflozin 10 mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
End Stage Renal Disease (ESRD) is defined as:
- Sustained eGFR <15 mL/min/1.73m2 or,
- Chronic dialysis treatment or,
- Receiving a kidney transplant
Measured: 12 months after randomization
Secondary outcomes (16)
Rate of decline in the estimated Glomerular Filtration Rate
Difference between eGFR at any timepoint and the initial eGFR
Measured: month 3, 9 and12 after randomization
Variation of albuminuria
Difference between albuminuria at at any timepoint and the initial albuminuria (expressed as albumin to creatinine ratio)
Measured: month 3, 9 and12 after randomization
Variation of HbA1C
Difference between HbA1C at at any timepoint and the initial HbA1C
Measured: month 3, 9 and12 after randomization
Variation of serum cholesterol levels
Difference between serum cholesterol at at any timepoint and the initial serum cholesterol
Measured: month 3, 9 and12 after randomization
Variation of serum bicarbonate levels
Difference between serum bicarbonate at at any timepoint and the initial serum bicarbonate
Measured: month 3, 9 and12 after randomization
Variation of serum potassium levels
Difference between serum potassium at at any timepoint and the initial serum potassium
Measured: month 3, 9 and12 after randomization
Variation of serum sodium levels
Difference between serum sodium at at any timepoint and the initial serum sodium
Measured: month 3, 9 and12 after randomization
Variation of hemoglobin levels
Difference between hemoglobin at at any timepoint and the initial serum hemoglobin
Measured: month 3, 9 and12 after randomization
Variation of hematocrit levels
Difference between hematocrit at at any timepoint and the initial hematocrit
Measured: month 3, 9 and12 after randomization
All cause hospitalizations
Percentage of patients who experienced hospitalizations of all cause
Measured: 12 months after randomization
Variation in body weight
Difference between body weight at at any timepoint and the body weight
Measured: month 3, 9 and12 after randomization
Variation in BMI
Difference between BMI at at any timepoint and the initial BMI
Measured: month 3, 9 and12 after randomization
Variation in handgrip strength
Difference between handgrip strength at at any timepoint and the initial handgrip strength
Measured: month 3, 9 and12 after randomization
Variation in serum albumin levels
Difference between serum albumin at at any timepoint and the initial serum albumin
Measured: month 3, 9 and12 after randomization
Variation in CRP levels
Difference between CRP at at any timepoint and the initial CRP
Measured: month 3, 9 and12 after randomization
Changes in the quality of life
Evaluated by SF-36 questionaire
Measured: month 3, 9 and12 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anemia Working Group Romania
- Sponsor type
- University, hospital or other
- Collaborators
- Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania, Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania, Carol Davila University of Medicine and Pharmacy
- Responsible party
- Sponsor
- Investigators
- Liliana Garneata, Professor, Principal investigator, Carol Davila University of Medicine and Pharmacy Bucharest, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281899
- Sponsor's protocol ID
- 01/2022
- Acronym
- PRODAPA-CKD
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06281899
- Acronym / sponsor ID
- PRODAPA-CKD / 01/2022
- Conditions
- Chronic Kidney Diseases, Type 2 Diabetes Mellitus
- Keywords
- chronic kidney disease, low protein diet, nutrition therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Anemia Working Group RomaniaUniversity, hospital or other
- Collaborators
- Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania, Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania, Carol Davila University of Medicine and Pharmacy
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The KDIGO Diabetes in CKD Guideline (2020) recommends the use of SGLT2i (level 1A) and suggests (level 2C) the prescription of plant protein-based low-protein diet in patients with chronic kidney disease (CKD) and diabetes mellitus (DM). Both interventions have shown synergistic nephroprotective effects, slowing the progression of chronic kidney disease by reducing glomerular hyperfiltration and proteinuria, thus resulting the hypothesis that by combining these two interventions it could be possible to achieve a superior control over the progression of diabetic kidney disease.
The nutritional intervention will consist in a mild protein restriction (0.6 g/kg dry ideal body weight) and a total recommended energy intake of 30-35 kcal/kg of ideal dry body weight per day in all patients. The protein intake will be checked through the food diary and calculated based on urea from 24 hours urine collection.
The efficacy and safety parameters will be evaluated during follow-up visits at month 1,2,3,6,12 and 18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Dapagliflozin 10 mg Tab, Behavioral: Low protein dietPatients 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 |
| Control | Active comparator | Drug: Dapagliflozin 10 mg TabPatients will receive Dapagliflozin 10 mg per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 mg TabDapagliflozin 10 mg once daily | Drug | Control, Intervention |
| Low protein dietPlant based low protein diet (0.6 g/kg IBW) | Behavioural | Intervention |
Primary outcome
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
Time frame: 12 months after randomization
End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR <15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a kidney transplant
16 secondary outcomes
Rate of decline in the estimated Glomerular Filtration Rate
Time frame: month 3, 9 and12 after randomization
Variation of albuminuria
Time frame: month 3, 9 and12 after randomization
Variation of HbA1C
Time frame: month 3, 9 and12 after randomization
Variation of serum cholesterol levels
Time frame: month 3, 9 and12 after randomization
Variation of serum bicarbonate levels
Time frame: month 3, 9 and12 after randomization
Variation of serum potassium levels
Time frame: month 3, 9 and12 after randomization
Variation of serum sodium levels
Time frame: month 3, 9 and12 after randomization
Variation of hemoglobin levels
Time frame: month 3, 9 and12 after randomization
Variation of hematocrit levels
Time frame: month 3, 9 and12 after randomization
All cause hospitalizations
Time frame: 12 months after randomization
Variation in body weight
Time frame: month 3, 9 and12 after randomization
Variation in BMI
Time frame: month 3, 9 and12 after randomization
Variation in handgrip strength
Time frame: month 3, 9 and12 after randomization
Variation in serum albumin levels
Time frame: month 3, 9 and12 after randomization
Variation in CRP levels
Time frame: month 3, 9 and12 after randomization
Changes in the quality of life
Time frame: month 3, 9 and12 after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liliana Garneata, Professor principal investigator
Carol Davila University of Medicine and Pharmacy Bucharest, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10 mg Tab and Low protein diet in people with Chronic Kidney Diseases and Type 2 Diabetes Mellitus, run by Anemia Working Group Romania at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liliana Garneata, Professor (+40722619358, lilianagarna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.