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

• Molecular-genetic diagnosis or diagnosis established by kidney biopsy
• Stable RAS blockade as background therapy.
• Signed and dated written informed consent.

Key exclusion criteria:

• Medical history that might limit the individual's ability to take trial treatments.
• Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.
• eGFR<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation
• Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).
• Known hypersensitivity or allergy to the investigational products.
• Any previous or current alcohol or drug abuse.
• Participation in another trial with an investigational drug ongoing.
• Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.