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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
Dapagliflozin (standard dose 10 mg p.o. once daily)
Placebo (standard dose p.o. once daily)
Universitätsklinikum Heidelberg - Children
Heidelberg, Baden-Württenberg, Germany
RECRUITINGLMU Klinikum
München, Bavaria, Germany
RECRUITINGv. Haunersches Kinderhospital
München, Bavaria, Germany
RECRUITINGUniversitätsklinikum Hamburg-Eppendorf - Adults
Hamburg, Hamburg, Germany
RECRUITINGUniversitätsklinikum Hamburg-Eppendorf - Children
Hamburg, Hamburg, Germany
RECRUITINGClementine Kinderhospital
Frankfurt am Main, Hesse, Germany
RECRUITINGUniversity Medicine Goettingen - Adults
Göttingen, Lower Saxony, Germany
RECRUITINGUniversity Medicine Goettingen - Childrens Hospital
Göttingen, Lower Saxony, Germany
RECRUITINGUniversitätsklinik Köln - Adults
Cologne, North Rhine-Westphalia, Germany
RECRUITINGUniversitätsklinik Köln - Children
Cologne, North Rhine-Westphalia, Germany
RECRUITING...and 6 more locations
Primary endpoint
Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks
Time frame: 48 weeks
Key secondary efficacy endpoint
Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment)
Time frame: 52 weeks
Key secondary safety endpoint
Adverse events (including serious adverse events)
Time frame: 52 weeks
Adverse events (AE) of special interest
(a) Ketoacidosis or symptomatic hypoglycemic event.
Time frame: 52 weeks
Adverse events (AE) of special interest
(b) Hyperkalemia (potassium levels ≥15% of the upper normal limit)
Time frame: 52 weeks
Adverse events (AE) of special interest
(c) Decline in eGFR of ≥ 30% relative from baseline eGFR.
Time frame: 52 weeks
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