Using Dapagliflozin to Treat Chronic Kidney Disease in Young People

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, in preventing the progression of chronic kidney disease (CKD) in adolescents and young adults diagnosed with Alport syndrome. The study will compare the effects of dapagliflozin against a placebo in patients with early stages of CKD, focusing on reducing albuminuria and delaying the onset of end-stage kidney failure. By establishing the safety and efficacy of this treatment in a pediatric population, the trial seeks to address a significant unmet medical need in this demographic.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universitätsklinikum Heidelberg - Children
  Heidelberg, Baden-Württenberg, Germany Recruiting
• LMU Klinikum
  München, Bavaria, Germany Recruiting
• v. Haunersches Kinderhospital
  München, Bavaria, Germany Recruiting
• Universitätsklinikum Hamburg-Eppendorf - Adults
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
• Universitätsklinikum Hamburg-Eppendorf - Children
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
• Clementine Kinderhospital
  Frankfurt am Main, Hesse, Germany Recruiting

Study contacts

• Principal investigator: Oliver Gross, MD — University Medicine Goettingen, Germany
• Study coordinator: Oliver Gross, MD
• Email: gross.oliver@med.uni-goettingen.de
• Phone: +4955139

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.