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ASPIRE-1: Individual and combined endothelin receptor and SGLT2 antagonism in adults with type 1 diabetes mellitus and chronic kidney disease: a Phase 2, multicenter, open-label randomized cross-over trial

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504404-28-00
Enrollment
26
Registered
2026-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-03

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

Conditions

Chronic Kidney Disease, Type 1 Diabetes

Brief summary

Change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.

Detailed description

Change from baseline in markers of fluid retention (body weight, hemoglobin, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)), Extracellular Volume (ECV), blood pressure, and estimated glomerular filtration rate (eGFR)when treated with SC0062 or dapagliflozin alone versus combination of dapagliflozin and SC0062. Safety: To assess the incidence, severity and seriousness of adverse events during treatment with SC0062 and/or dapagliflozin.

Interventions

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.

Secondary

MeasureTime frame
Change from baseline in markers of fluid retention (body weight, hemoglobin, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)), Extracellular Volume (ECV), blood pressure, and estimated glomerular filtration rate (eGFR)when treated with SC0062 or dapagliflozin alone versus combination of dapagliflozin and SC0062. Safety: To assess the incidence, severity and seriousness of adverse events during treatment with SC0062 and/or dapagliflozin.

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026