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

Sponsor
University Hospital Goettingen
Study ID
NCT05944016
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Kidney Failure in Children and Young Adults

Eligibility Criteria

Sex
ALL
Age
10 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin (standard dose 10 mg p.o. once daily)
  • Placebo — DRUG
    Placebo (standard dose p.o. once daily)

Study Details

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.

Key Dates

Start date
Mar 25, 2024
Status verified
May 2024
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin (standard dose 10 mg p.o. once daily).
  • Placebo Comparator: Placebo
    Placebo therapy.

Primary Outcome Measure

Primary endpoint [ Time Frame: 48 weeks ]

Central Contacts