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DAPARHT
NCT05321706Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2022
- Primary completion
- Sep 2028
- Countries
- 3
- Sponsor
- Oslo University Hospital
- Modality
- Small Molecules
- Drugs
- dapagliflozin
- Conditions
- kidney failure (ESRD)
01
Overview
Phase 3, randomised, double-blind trial in kidney failure (ESRD) comparing Dapagliflozin with Placebo (2 arms). Primary endpoints: Chronic slope of the estimated glomerular filtration rate at 12 months and Change in estimated glomerular filtration rate from baseline at 37 months. Started Jun 2022; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dapagliflozin
Dapagliflozin 10 mg oral once daily
Placebo
Matching placebo oral once daily
03
Who it enrols
Adult heart transplant recipients (≥ 1 year post-transplant) with eGFR ≥ 25 ml/min/m2, excluding those with Type I diabetes, severe liver failure, unresolved malignancy, or recent SGLT2 inhibitor use.
04
Endpoints
Primary
Chronic slope of the estimated glomerular filtration rate
Change in estimated glomerular filtration rate from baseline
Secondary
Body weight
Glycosylated hemoglobin
Proteinuria
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