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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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