Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Dapagliflozin 10 mg Tab for Chronic Kidney Diseases

This is a prospective multicenter randomly assigned controlled trial with a total duration of 36 months aiming to measure 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

Official registry: https://clinicaltrials.gov/study/NCT06281899 · Anemia Working Group Romania · enrollment listed as 200

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dapagliflozin 10 mg Tab, or Low protein diet. The registry lists allocation as randomized. This is a prospective multicenter randomly assigned controlled trial with a total duration of 36 months aiming to measure 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

They plan to enroll about 200 people at Bucharest. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

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

Interventions: Dapagliflozin 10 mg Tab, Low protein diet

Primary outcome (registry wording): 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

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Liliana Garneata, Professor

+40722619358

lilianagarna@yahoo.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06281899 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06281899?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06281899?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary