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

Recruiting Phase 3 Interventional Study
Chronic Kidney Failure in Children and Young Adults
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
10 – 39
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
102 (estimated)
Sponsor
University Hospital Goettingen · Other
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About This Trial
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 p…
Trial Locations
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Eligibility Criteria
Key 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 creatinine) AND * eGFR ≥ 30 ml/min/1.73 m2 OR * adults ≥ 18 to \< 40 years with albuminuria (UACR ≥ 500mg/g creatinine…
Contacts

Oliver Gross, MD

+4955139

gross.oliver@med.uni-goettingen.de

CONTACT