Tests dapagliflozin to slow kidney disease in young people with Alport syndrome
Tests dapagliflozin against placebo in young people with Alport syndrome kidney disease.
Plain-language title generated from the registry record
Registry title: Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Key facts
- Where
- Berlin, Cologne, Frankfurt am Main, Göttingen, Hamburg, Heidelberg, Leipzig, München, and Münster, GermanySee the 16 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 39 years old?
Source: NCT05944016, who can take part
Where in Germany
- Charite Berlin - AdultsBerlin, GermanyTaking people
- Charite Berlin - ChildrenBerlin, GermanyTaking people
- Universitätsklinik Köln - AdultsCologne, GermanyTaking people
- Universitätsklinik Köln - ChildrenCologne, GermanyTaking people
- Clementine KinderhospitalFrankfurt am Main, GermanyTaking people
- University Medicine Goettingen - AdultsGöttingen, GermanyTaking people
- University Medicine Goettingen - Childrens HospitalGöttingen, GermanyTaking people
- Universitätsklinikum Hamburg-Eppendorf - AdultsHamburg, GermanyTaking people
- Universitätsklinikum Hamburg-Eppendorf - ChildrenHamburg, GermanyTaking people
- Universitätsklinikum Heidelberg - ChildrenHeidelberg, GermanyTaking people
- Universitätsklinik Leipzig - ChildrenLeipzig, GermanyTaking people
- Universitätsklinikum Leipzig - AdultsLeipzig, GermanyTaking people
- LMU KlinikumMünchen, GermanyTaking people
- v. Haunersches KinderhospitalMünchen, GermanyTaking people
- Universitätsklinik Münster - AdultsMünster, GermanyNot yet recruiting
- Universitätsklinikum Münster - ChildrenMünster, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Goettingen
- Trial code
- NCT05944016EU 2023-508502-18-00
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
DOUBLE PRO-TECT Alport: A Confirmatory, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Dapagliflozin on the Progression of Chronic Kidney Disease in Adolescents and Young Adult Patients With Alport Syndrome
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.
Inclusion: 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.
Exclusion: Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1; 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; Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg); eGFR<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation; Medical history that might limit the individual's ability to take trial treatments; Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.