Heart transplant, Kidney failure
Conditions
Brief summary
The primary endpoint will be the slope of the eGFR from 2 weeks to end-of-treatment (12 months), calculated as the difference in eGFR from two weeks to 12 months after start of the intervention. The eGFR is calculated from serum creatinine using the Modification of Diet in Renal Disease (MDRD) formula
Detailed description
Baseline-adjusted body weight, The change in the albumin / creatinine ratio in the urine from baseline to end-of-treatment in patients with a baseline ratio > 30 mg/g at baseline, The change in the blood level of glycated haemoglobin (HbA1c) in patients with diabetes mellitus, Change in body composition (exploratory endpoint), Biomarkers of renal damage (i.e. Cystatin-C, Lipocalin (NGAL), KIM-1, osteopontin) (exploratory endpoints)
Interventions
DRUGDAPAGLIFLOZIN
Sponsors
Oslo University Hospital HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the slope of the eGFR from 2 weeks to end-of-treatment (12 months), calculated as the difference in eGFR from two weeks to 12 months after start of the intervention. The eGFR is calculated from serum creatinine using the Modification of Diet in Renal Disease (MDRD) formula | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline-adjusted body weight, The change in the albumin / creatinine ratio in the urine from baseline to end-of-treatment in patients with a baseline ratio > 30 mg/g at baseline, The change in the blood level of glycated haemoglobin (HbA1c) in patients with diabetes mellitus, Change in body composition (exploratory endpoint), Biomarkers of renal damage (i.e. Cystatin-C, Lipocalin (NGAL), KIM-1, osteopontin) (exploratory endpoints) | — |
Countries
Netherlands, Norway, Sweden
Outcome results
None listed