Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Recruiting · NCT05944016 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Goettingen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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) AND
- eGFR ≥ 60 ml/min/1.73 m2
- Molecular-genetic diagnosis or diagnosis established by kidney biopsy
- Stable RAS blockade as background therapy.
- Signed and dated written informed consent.
- Key
Exclusion criteria
- 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).
- Known hypersensitivity or allergy to the investigational products.
- Any previous or current alcohol or drug abuse.
- Participation in another trial with an investigational drug ongoing.
- Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.
Where it is running
16 locations listed.
- Universitätsklinikum Heidelberg - Children - Heidelberg, Baden-Württenberg, Germany
- LMU Klinikum - München, Bavaria, Germany
- v. Haunersches Kinderhospital - München, Bavaria, Germany
- Universitätsklinikum Hamburg-Eppendorf - Adults - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Universitätsklinikum Hamburg-Eppendorf - Children - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Clementine Kinderhospital - Frankfurt am Main, Hesse, Germany
- University Medicine Goettingen - Adults - Göttingen, Lower Saxony, Germany
- University Medicine Goettingen - Childrens Hospital - Göttingen, Lower Saxony, Germany
- Universitätsklinik Köln - Adults - Cologne, North Rhine-Westphalia, Germany
- Universitätsklinik Köln - Children - Cologne, North Rhine-Westphalia, Germany
- Universitätsklinik Münster - Adults - Münster, North Rhine-Westphalia, Germany
- Universitätsklinikum Münster - Children - Münster, North Rhine-Westphalia, Germany
- Universitätsklinik Leipzig - Children - Leipzig, Saxony, Germany
- Universitätsklinikum Leipzig - Adults - Leipzig, Saxony, Germany
- Charite Berlin - Adults - Berlin, State of Berlin, Germany
- Charite Berlin - Children - Berlin, State of Berlin, Germany