Przewlekła choroba nerek: badanie fazy III leku dapagliflozin

Kryteria wyłączenia kto nie może wziąć udziału (22)

1. Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation
2. UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening.
3. SBP > 180 mmHg or DBP > 110 mmHg at screening.
4. SBP < 90 mmHg at screening.
5. HbA1c > 9% at screening
6. T1DM, except:
7. For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible.
8. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
9. Autosomal dominant polycystic kidney disease.
10. Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening.
11. Severe hepatic impairment (Child-Pugh Class C).
12. Adrenal insufficiency.
13. Clinically significant acute kidney injury within 12 weeks prior to the screening.
14. New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening.
15. Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening.
16. Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation.
17. Any use of the following medications and supplements:
18. MRAs
19. Aldosterone analogues
20. Aldosterone synthase inhibitors
21. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.
22. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation