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

Study acronym: DOUBLE_PROTECT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 16, 2024 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site details revised at 16 of 16 sitesv6
  2. Start date changed from estimate of Mar 10, 2024 to Mar 25, 2024v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 2026 to Sep 2026
    • Start date: Feb 2024 to Mar 10, 2024
    • Site details revised at 16 of 16 sites
    v4
  4. Lead sponsor: Prof. Dr. O. Gross to University Hospital Goettingen
    • Start date: Dec 2023 to Feb 2024
    v3
  5. Study sites: 0 to 16
    • Eligibility criteria expanded, about 4 words
    • Collaborators expanded, about 3 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05944016
Lead Sponsor University Hospital Goettingen
Collaborators: German Research Foundation
Conditions
(from sponsor)		 Chronic Kidney Failure in Children and Young Adults
Related terms Nephritis, Hereditary
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov