Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients

Phase 3

Recruiting

• Conditions: Chronic Kidney Failure in Children and Young Adults
• Interventions: Drug: Placebo; Drug: Dapagliflozin

• Registration Number: NCT05944016
• Lead Sponsor: University Hospital Goettingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-01
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-13
• Study Start: 2024-03-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo therapy.
Dapagliflozin	Dapagliflozin	Dapagliflozin (standard dose 10 mg p.o. once daily).

Primary Outcome Measures

Name	Time	Method
Primary endpoint	48 weeks	Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks

Secondary Outcome Measures

Name	Time	Method
Key secondary safety endpoint	52 weeks	Adverse events (including serious adverse events)
Adverse events (AE) of special interest	52 weeks	(c) Decline in eGFR of ≥ 30% relative from baseline eGFR.
Key secondary efficacy endpoint	52 weeks	Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment)

Trial Locations

Locations (16)

Universitätsklinikum Heidelberg - Children; 🇩🇪 Heidelberg, Baden-Württenberg, Germany

LMU Klinikum; 🇩🇪 München, Bayern, Germany

v. Haunersches Kinderhospital; 🇩🇪 München, Bayern, Germany

Clementine Kinderhospital; 🇩🇪 Frankfurt, Hessen, Germany

University Medicine Goettingen - Adults; 🇩🇪 Göttingen, Lower Saxony, Germany

University Medicine Goettingen - Childrens Hospital; 🇩🇪 Göttingen, Lower Saxony, Germany

Universitätsklinik Köln - Adults; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Universitätsklinik Köln - Children; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Universitätsklinik Münster - Adults; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Universitätsklinikum Münster - Children; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Universitätsklinik Leipzig - Children; 🇩🇪 Leipzig, Sachsen, Germany

Universitätsklinikum Leipzig - Adults; 🇩🇪 Leipzig, Sachsen, Germany

Charite Berlin - Adults; 🇩🇪 Berlin, Germany

Charite Berlin - Children; 🇩🇪 Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf - Adults; 🇩🇪 Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf - Children; 🇩🇪 Hamburg, Germany