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NCT06281899: PRODAPA-CKD
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Phase 4 trial testing Dapagliflozin 10 mg Tab in Chronic Kidney Diseases in 200 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Anemia Working Group Romania |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 January 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 March 2025 |
| Sites | 1 location across Romania |
Drugs / interventions tested
- Dapagliflozin 10 mg Tab — full drug profile →
- Low protein diet
Conditions studied
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Anemia Working Group Romania — full company profile →
Who can join
18 and older, any sex, with Chronic Kidney Diseases or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06281899
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dapagliflozin 10 mg Tab
Trials testing the same drug.
- NCT05392959 — Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabeti · Phase 4 · terminated
Other recruiting trials for Chronic Kidney Diseases
Currently open trials in the same condition.
- NCT06593392 — Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus · Phase 2 · recruiting
- NCT07358572 — Eye-Brain-Kidney in CKD · recruiting
- NCT06463483 — Automated Insulin Delivery in Adults With Advanced Kidney Disease · NA · recruiting
- NCT06927024 — Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD) · NA · recruiting
- NCT07115953 — Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension · NA · recruiting
Other Anemia Working Group Romania trials
Trials by the same sponsor.
- NCT03415074 — Could Ketoanalogue-supplemented Low Protein Diet Defer Dialysis in Advanced Diabetic Kidney Disease? (K-DDD) · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06281899 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Anemia Working Group Romania
- Last refreshed: 28 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06281899.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing