A Phase IIb Dose-Finding Study of Balcinrenone/Dapagliflozin in Patients with CKD and Albuminuria.

JRCT ID: jRCT2031240054

Registered date:26/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Choronic Kindney Disease and Albuminuria
• Date of first enrollment: 01/07/2024
• Target sample size: 35
• Countries of recruitment: Brazil,Japan,Canada,Japan,Chile,Japan,United States of America,Japan,Austria,Japan,Bulgaria,Japan,Italy,Japan,Poland,Japan,Spain,Japan,United Kingdom,Japan,China,Japan,Malaysia,Japan,Taiwan,Japan,Turkey,Japan,Vietnam,Japan
• Study type: Interventional
• Intervention(s): Balcinrenone/dapagliflozin 15 mg/10 mg, Balcinrenone/dapagliflozin 40 mg/10 mg, Dapagliflozin 10 mg

Outcome(s)

• Primary Outcome: Relative change in UACR from baseline to Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participant must be 18 or more years old, at the time of signing the informed consent.

2. Diagnosis of CKD and eGFR 25 or more and below 60 mL/min/1.73 m2 at screening (Visit 1).

3. UACR above 100 mg/g (10 mg/mmol) and 5000 mg/g or less (500 mg/mmol) at screening (Visit 1).

4. Serum potassium 3.5 mmol/L or more and 5.0 mmol/L or less at screening (Visit 1).

5. Participants treated with RAAS inhibitors must be on a stable dose for at least 4 weeks before screening.

Exclude criteria

1. Uncontrolled arterial hypertension at screening (Visit 1).

2. Hypotension defined as mean of 3 consecutive measurements of SBP below 100 mmHg at screening (Visit 1).

3. Myocardial infarction, acute coronary syndrome, stroke, transient ischaemic attack within 12 weeks prior to randomisation (Visit 2).

4. Lupus nephritis or antineutrophil cytoplasmic antibody-associated vasculitis, or other nephropathies that are unstable, or progress rapidly, or require cytotoxic or immunomodulatory therapy.

5. Diagnosis of autosomal dominant polycystic kidney disease.

6. Recent (within 90 days prior to screening) or ongoing dialysis, or in the opinion of the investigator likely need for dialysis within 3 months following randomisation (Visit 2).

7. Hepatic disease, including active HBV or HCV infection.

8. T1DM or uncontrolled T2DM Serum HCO3 below 18 mmol/L at screening (Visit 1).

9. Suspected (as judged by PI) or confirmed COVID-19 infection within the last 4 weeks prior to screening (Visit 1) or at randomisation (Visit 2).

10. Hospitalisation for COVID-19 within the last 12 weeks prior to screening (Visit 1).

11. History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma or in situ carcinoma of the cervix.

12. MRA within 4 weeks prior to screening (Visit 1) or planned initiation of MRA treatment.

13. Potassium sparing diuretics (eg, amiloride, triamterene) within 4 weeks prior to screening (Visit 1).

14. Potassium binders within 4 weeks prior to screening (Visit 1).

15. Aldosterone analogue fludrocortisone within 4 weeks prior to screening (Visit 1).

16. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation (Visit 2)

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06350123