Chronic Kidney Disease, Type 1 Diabetes
Conditions
Brief summary
Primary: change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.
Detailed description
Secondary: 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
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: 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