RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: University Hospital Goettingen • ClinicalTrials.gov ID: NCT05944016

Registry updated: 2026-10-16

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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.

Interventions

Dapagliflozin (Drug)
Dapagliflozin (standard dose 10 mg p.o. once daily)
Placebo (Drug)
Placebo (standard dose p.o. once daily)

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) AND * eGFR ≥ 60 ml/min/1.73 m2 1. Molecular-genetic diagnosis or diagnosis established by kidney biopsy 2. Stable RAS blockade as background therapy. 3. Signed and dated written informed consent. Key exclusion criteria: 1. Medical history that might limit the individual's ability to take trial treatments. 2. Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1. 3. eGFR\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation 4. Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg). 5. Known hypersensitivity or allergy to the investigational products. 6. Any previous or current alcohol or drug abuse. 7. Participation in another trial with an investigational drug ongoing. 8. Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.

Conditions

Chronic Kidney Failure in Children and Young Adults

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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