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New treatment option for Chronic Kidney Failure in Children and Young Adults
Official title Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
ClinicalTrials.gov ID: NCT05944016
What this study is testing
What is Dapagliflozin?
Dapagliflozin is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic kidney failure in children and young adults.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 39
You may be able to join if
- Key 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
You likely can't join if
- Medical history that might limit the individual's ability to take trial treatments.
- Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.
- eGFR\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation
- Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).
- Known hypersensitivity or allergy to the investigational products.
- Any previous or current alcohol or drug abuse.
See the full eligibility criteria
- Key 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
- Molecular-genetic diagnosis or diagnosis established by kidney biopsy
- Stable RAS blockade as background therapy.
- Signed and dated written informed consent. Key
- Medical history that might limit the individual's ability to take trial treatments.
- Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.
- eGFR\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation
- Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).
- Known hypersensitivity or allergy to the investigational products.
- Any previous or current alcohol or drug abuse.
- Participation in another trial with an investigational drug ongoing.
- Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Württenberg, Germany
- München, Bavaria, Germany
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Frankfurt am Main, Hesse, Germany
- Göttingen, Lower Saxony, Germany
- Cologne, North Rhine-Westphalia, Germany
- Münster, North Rhine-Westphalia, Germany
- Leipzig, Saxony, Germany
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Württenberg, Germany; München, Bavaria, Germany; Hamburg, Free and Hanseatic City of Hamburg, Germany; Frankfurt am Main, Hesse, Germany; Göttingen, Lower Saxony, Germany; Cologne, North Rhine-Westphalia, Germany and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.