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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 adolescent and young adult patients with Alport syndrome
EU CTIS ID: 2023-508502-18-00
What this study is testing
Recent trials have demonstrated positive renal outcomes of sodium–glucose co-transporter-2 inhibitors (SGLT2i) additive to ACEis in adult patients with diabetic and non-diabetic CKD [6-9]. These trials included less than 10 adult AS patients and no children. Our hypothesis is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of AS in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of ESKF and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with AS, who have a very high unmet medical need.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Early stages of CKD with established diagnosis of Alport syndrome at visit 1 (screening)
- adolescents ≥ 10 to < 18 years with albuminuria (UACR ≥ 300mg/g Crea) OR adults ≥ 18 to < 40 years with albuminuria (UACR ≥ 500mg/g Crea) AND eGFR ≥ 60 ml/min/1.73 m2
- Molecular-genetic diagnosis (any type of Alport gene variant) or diagnosis established by kidney biopsy
- Stable RAS blockade as standard of care background therapy (defined as no adjustment to dose in the last three months prior the baseline visit).
- Signed and dated written informed consent
You likely can't join if
- Medical history that might limit the individual’s ability to take trial treatments
- Lack of basic understanding of German language (required for patient questionnaires)
- Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1
- Requiring dialysis or after kidney-transplantation
- Uncontrolled arterial hypertension (blood pressure >145/95 mmHg)
- Type 1 diabetes OR type 2 diabetes with previous history of diabetic ketoacidosis
See the full eligibility 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 Crea) OR adults ≥ 18 to < 40 years with albuminuria (UACR ≥ 500mg/g Crea) AND eGFR ≥ 60 ml/min/1.73 m2
- Molecular-genetic diagnosis (any type of Alport gene variant) or diagnosis established by kidney biopsy
- Stable RAS blockade as standard of care background therapy (defined as no adjustment to dose in the last three months prior the baseline visit).
- Signed and dated written informed consent
- Medical history that might limit the individual’s ability to take trial treatments
- Lack of basic understanding of German language (required for patient questionnaires)
- Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1
- Requiring dialysis or after kidney-transplantation
- Uncontrolled arterial hypertension (blood pressure >145/95 mmHg)
- Type 1 diabetes OR type 2 diabetes with previous history of diabetic ketoacidosis
- Known hypersensitivity or allergy to the investigational product (contains lactulose)
- Any previous or current alcohol or drug abuse
- Participation in another trial with an investigational drug ongoing
- Pre-menopausal 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.
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.