Dapagliflozin for Chronic Kidney Disease in Young Patients
Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Recruiting
Phase 3
Interventional Study
Chronic Kidney Failure in Children and Young Adults
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 10 – 39
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 102 (estimated)
- Sponsor
- University Hospital Goettingen · Other
Who this trial is looking for
This trial is looking for adolescents and young adults with early stages of chronic kidney disease (CKD) caused by Alport syndrome. Participants will take a medication called dapagliflozin to see if it helps protect their kidneys from worsening.
Are You a Good Fit for This Trial?
You may be able to join if
- I have early stages of CKD and have been diagnosed with Alport syndrome.
- I am an adolescent between 10 and 18 years old with albuminuria.
- I am an adult between 18 and 40 years old with albuminuria.
- My estimated kidney function (eGFR) is 30 mL/min/1.73 m2 or higher.
- I have a stable RAS blockade treatment.
- I have signed informed consent.
You may not be able to join if
- I have medical issues that limit my ability to take trial treatments.
- I have taken any SGLT2 inhibitor in the last 4 weeks.
- My eGFR is less than 60 mL/min/1.73 m2.
- I have uncontrolled high blood pressure.
- I am allergic to the trial medications.
- I have a history of alcohol or drug abuse.
- I am participating in another trial with an investigational drug.
- I am pregnant, nursing, or not using acceptable birth control.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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About This Trial
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 p…
Trial Locations
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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…
Contacts