Using Dapagliflozin to Treat Chronic Kidney Disease in Young People
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
This study is testing if the medication dapagliflozin can help young people with Alport syndrome and early chronic kidney disease slow down kidney damage and reduce protein in their urine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 10 Years to 39 Years |
| Sex | All |
| Sponsor | University Hospital Goettingen Academic / other |
| Locations | 16 sites (Heidelberg, Baden-Württenberg and 15 other locations) |
| Trial ID | NCT05944016 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adolescents aged 10 to 18 years or young adults aged 18 to 40 years with early-stage Alport syndrome and specific levels of albuminuria.
Not a fit: Patients with advanced CKD, requiring dialysis, or those with uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly delay the progression of kidney disease and improve the quality of life for affected young patients.
How similar studies have performed: Previous studies have shown positive outcomes with SGLT2 inhibitors in adult populations, but this approach in children is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Heidelberg, Baden-Württenberg and 15 other locations
- 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)
- University Medicine Goettingen - Adults — Göttingen, Lower Saxony, Germany (Recruiting)
- University Medicine Goettingen - Childrens Hospital — Göttingen, Lower Saxony, Germany (Recruiting)
- Universitätsklinik Köln - Adults — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinik Köln - Children — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinik Münster - Adults — Münster, North Rhine-Westphalia, Germany (Not_yet_recruiting)
- Universitätsklinikum Münster - Children — Münster, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinik Leipzig - Children — Leipzig, Saxony, Germany (Recruiting)
- Universitätsklinikum Leipzig - Adults — Leipzig, Saxony, Germany (Recruiting)
- Charite Berlin - Adults — Berlin, State of Berlin, Germany (Recruiting)
- Charite Berlin - Children — Berlin, State of Berlin, 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.