Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-39
SponsorUniversity Hospital Goettingen
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 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.
Eligibility criteria
Qualifiers
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) AND
eGFR ≥ 60 ml/min/1.73 m2
Disqualifiers
Medical history that might limit the individual's ability to take trial treatments.
Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.
eGFR<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation
Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).
Trial design
Treatments tested in this trial
- Dapagliflozin
- Placebo
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital Goettingen
Lead sponsor
German Research Foundation
Collaborator
Source ClinicalTrials.gov