DOUBLE PRO-TECT Alport: a Confirmatory, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Dapagliflozin on the Progression of Chronic Kidney Disease in Adolescents and Young Adult Patients with Alport Syndrome
Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.
∙ 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.