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 adolescent and young adult patients with Alport syndrome

Phase 1

Conditions: Alport syndrome
MedDRA version: 20.0Level: PTClassification code: 10001843Term: Alport's syndrome Class: 100000004850
Therapeutic area: Not possible to specify

Registration Number: CTIS2023-508502-18-00

Lead Sponsor: niversitaetsmedizin Goettingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 102

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 Crea) OR adults = 18 to < 40 years with albuminuria (UACR = 500mg/g Crea) AND eGFR = 60 ml/min/1.73 m2, Molecular-genetic diagnosis (any type of Alport gene variant) or diagnosis established by kidney biopsy, Stable RAS blockade as standard of care background therapy (defined as no adjustment to dose in the last three months prior the baseline visit)., Signed and dated written informed consent

Exclusion Criteria

Medical history that might limit the individual’s ability to take trial treatments, Lack of basic understanding of German language (required for patient questionnaires), Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1, Requiring dialysis or after kidney-transplantation, Uncontrolled arterial hypertension (blood pressure >145/95 mmHg), Type 1 diabetes OR type 2 diabetes with previous history of diabetic ketoacidosis, Known hypersensitivity or allergy to the investigational product (contains lactulose), Any previous or current alcohol or drug abuse, Participation in another trial with an investigational drug ongoing, Pre-menopausal women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control