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Clinical Trial Details

Trial ID: L0444
Source ID: NCT06281899
Associated Drug: Dapagliflozin 10 Mg Tab
Title: Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Acronym: PRODAPA-CKD
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin 10 mg Tab|BEHAVIORAL: Low protein diet
Outcome Measures: Primary: 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, 12 months after randomization | Secondary: Rate of decline in the estimated Glomerular Filtration Rate, Difference between eGFR at any timepoint and the initial eGFR, 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), month 3, 9 and12 after randomization|Variation of HbA1C, Difference between HbA1C at at any timepoint and the initial HbA1C, month 3, 9 and12 after randomization|Variation of serum cholesterol levels, Difference between serum cholesterol at at any timepoint and the initial serum cholesterol, month 3, 9 and12 after randomization|Variation of serum bicarbonate levels, Difference between serum bicarbonate at at any timepoint and the initial serum bicarbonate, month 3, 9 and12 after randomization|Variation of serum potassium levels, Difference between serum potassium at at any timepoint and the initial serum potassium, month 3, 9 and12 after randomization|Variation of serum sodium levels, Difference between serum sodium at at any timepoint and the initial serum sodium, month 3, 9 and12 after randomization|Variation of hemoglobin levels, Difference between hemoglobin at at any timepoint and the initial serum hemoglobin, month 3, 9 and12 after randomization|Variation of hematocrit levels, Difference between hematocrit at at any timepoint and the initial hematocrit, month 3, 9 and12 after randomization|All cause hospitalizations, Percentage of patients who experienced hospitalizations of all cause, 12 months after randomization|Variation in body weight, Difference between body weight at at any timepoint and the body weight, month 3, 9 and12 after randomization|Variation in BMI, Difference between BMI at at any timepoint and the initial BMI, month 3, 9 and12 after randomization|Variation in handgrip strength, Difference between handgrip strength at at any timepoint and the initial handgrip strength, month 3, 9 and12 after randomization|Variation in serum albumin levels, Difference between serum albumin at at any timepoint and the initial serum albumin, month 3, 9 and12 after randomization|Variation in CRP levels, Difference between CRP at at any timepoint and the initial CRP, month 3, 9 and12 after randomization|Changes in the quality of life, Evaluated by SF-36 questionaire, month 3, 9 and12 after randomization | Other: Compliance to the protein intake, Achieved protein intake will be estimated based on urinary urea excretion, using Mitch-Maroni's formula, month 1, 3, 9 and12 after randomization|Compliance to the energy intake, Achieved energy intake will be estimated using the 3-day food diary to calculate the daily energy intake, month 1, 3, 9 and12 after randomization|Compliance to carbohydrate intake, Achieved energy intake will be estimated by the 3-day food diary to calculate thecarbohydrates intake, month 1, 3, 9 and12 after randomization
Sponsor/Collaborators: Sponsor: Anemia Working Group Romania | 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
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2025-03-31
Results First Posted:
Last Update Posted: 2024-02-28
Locations: Carol Davila University of Medicine and Pharmacy Bucharest, Bucharest, Romania
URL: https://clinicaltrials.gov/show/NCT06281899