RecruitingPhase 3NCT05944016

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

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

Sponsor

University Hospital Goettingen

Enrollment

102 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Failure in Children and Young Adults

Summary

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

Min Age: 10 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether dapagliflozin — a medication already used for diabetes and kidney disease in adults — can slow kidney disease progression in teenagers and young adults with Alport syndrome, a genetic condition that damages the kidneys. It is one of the first trials of this drug specifically for younger patients with this condition. **You may be eligible if...** - You are aged 10–17 with Alport syndrome, significant protein in your urine, and kidney function above a certain level - You are aged 18–39 with Alport syndrome, significant protein in your urine, and good kidney function - Your diagnosis has been confirmed by genetic testing or kidney biopsy - You are currently on stable kidney-protective medication (RAS blockade) **You may NOT be eligible if...** - You have been on an SGLT2 inhibitor (like dapagliflozin) recently - Your kidney function is significantly reduced, or you are on dialysis or have had a kidney transplant - You have uncontrolled high blood pressure or other conditions that would make the drug unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin

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

DRUGPlacebo

Placebo (standard dose p.o. once daily)

Locations(16)

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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NCT05944016