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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508502-18-00

Acronym

2023-01601

Enrollment

102

Registered

2024-02-07

Start date

2024-03-19

Completion date

Unknown

Last updated

2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alport syndrome

Brief summary

Change from baseline to 48 weeks in (log transformed) UACR.

Detailed description

eGFR change from baseline to Week 52, In adults, change from baseline to Week 48 in SF- 36., In adolescents, change from baseline to Week 48 in PedsQL, Difference between treatment groups in eGFR change from Week 4 eGFR to Week 48 measurement

Interventions

DRUGForxiga 5 mg film-coated tablets

DRUGP-Tabletten weiß 7 mm Lichtenstein

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline to 48 weeks in (log transformed) UACR.	—

Secondary

Measure	Time frame
eGFR change from baseline to Week 52, In adults, change from baseline to Week 48 in SF- 36., In adolescents, change from baseline to Week 48 in PedsQL, Difference between treatment groups in eGFR change from Week 4 eGFR to Week 48 measurement	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026