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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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 progression of the chronic kidney disease Alport syndrome 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 end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin (standard dose 10 mg p.o. once daily). |
|
| Placebo | Placebo Comparator | Placebo therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Dapagliflozin (standard dose 10 mg p.o. once daily) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary efficacy endpoint | Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment) | 52 weeks |
| Key secondary safety endpoint | Adverse events (including serious adverse events) |
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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
Key exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliver Gross, MD | Contact | +4955139 | 60488 | gross.oliver@med.uni-goettingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Gross, MD | University Medicine Goettingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Heidelberg - Children | Recruiting | Heidelberg | Baden-Württenberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39122650 | Background | Gross O, Boeckhaus J, Weber LT, Heerspink HJL, Simon JF, Ahmed R, Gerst C, Duerr U, Walker F, Tostmann R, Helm J, Asendorf T, Friede T; study group of the German Society of Pediatric Nephrology. Protocol and rationale for a randomized controlled SGLT2 inhibitor trial in paediatric and young adult populations with chronic kidney disease: DOUBLE PRO-TECT Alport. Nephrol Dial Transplant. 2025 Apr 1;40(4):679-687. doi: 10.1093/ndt/gfae180. | |
| 38308509 |
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IPD will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.
Documents will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.
IPD will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.
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Experimental intervention: Dapagliflozin (standard dose 10 mg p.o. once daily). Control intervention: Placebo therapy.
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double-blinded study using capsules.
| Placebo |
| Drug |
Placebo (standard dose p.o. once daily) |
|
| 52 weeks |
| Adverse events (AE) of special interest | (a) Ketoacidosis or symptomatic hypoglycemic event. | 52 weeks |
| Adverse events (AE) of special interest | (b) Hyperkalemia (potassium levels ≥15% of the upper normal limit) | 52 weeks |
| Adverse events (AE) of special interest | (c) Decline in eGFR of ≥ 30% relative from baseline eGFR. | 52 weeks |
| LMU Klinikum | Recruiting | München | Bavaria | 80336 | Germany |
|
| v. Haunersches Kinderhospital | Recruiting | München | Bavaria | 81337 | Germany |
|
| Universitätsklinikum Hamburg-Eppendorf - Adults | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
|
| Universitätsklinikum Hamburg-Eppendorf - Children | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20251 | Germany |
|
| Clementine Kinderhospital | Recruiting | Frankfurt am Main | Hesse | 60316 | Germany |
|
| University Medicine Goettingen - Adults | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
|
| University Medicine Goettingen - Childrens Hospital | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
|
| Universitätsklinik Köln - Adults | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
|
| Universitätsklinik Köln - Children | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
|
| Universitätsklinik Münster - Adults | Not yet recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
|
| Universitätsklinikum Münster - Children | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
|
| Universitätsklinik Leipzig - Children | Recruiting | Leipzig | Saxony | 04103 | Germany |
|
| Universitätsklinikum Leipzig - Adults | Recruiting | Leipzig | Saxony | 04103 | Germany |
|
| Charite Berlin - Adults | Recruiting | Berlin | State of Berlin | 10117 | Germany |
|
| Charite Berlin - Children | Recruiting | Berlin | State of Berlin | 10117 | Germany |
|
| Background |
| Gross O, Haffner D, Schaefer F, Weber LT. SGLT2 inhibitors: approved for adults and cats but not for children with CKD. Nephrol Dial Transplant. 2024 May 31;39(6):907-909. doi: 10.1093/ndt/gfae029. No abstract available. |
| ID | Term |
|---|---|
| D009394 | Nephritis, Hereditary |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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