Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients

Key inclusion criteria:

Early stages of CKD with established diagnosis of Alport syndrome at visit 1 (screening)

• adolescents ≥ 10 to < 18 years with albuminuria (UACR ≥ 300mg/g creatinine) AND

• eGFR ≥ 30 ml/min/1.73 m2 OR

• adults ≥ 18 to < 40 years with albuminuria (UACR ≥ 500mg/g creatinine) AND

• eGFR ≥ 60 ml/min/1.73 m2

1. Molecular-genetic diagnosis or diagnosis established by kidney biopsy

2. Stable RAS blockade as background therapy.

3. Signed and dated written informed consent.

Key exclusion criteria:

1. Medical history that might limit the individual's ability to take trial treatments.

2. Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.

3. eGFR<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or afterkidney-transplantation

4. Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).

5. Known hypersensitivity or allergy to the investigational products.

6. Any previous or current alcohol or drug abuse.

7. Participation in another trial with an investigational drug ongoing.

8. Women, who are nursing or pregnant, or who are not practicing an acceptable methodof birth control.