NCT05944016

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: University Hospital Goettingen · Academic / Other
• Sex: All
• Age: 10 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Kidney Failure in Children and Young Adults

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin (standard dose 10 mg p.o. once daily)
DRUG	Placebo	Placebo (standard dose p.o. once daily)

Timeline

• Start date: 2024-03-25
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-07-13
• Last updated: 2024-12-16

Locations

16 sites across 1 country: Germany