Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dapagliflozin Tab · 1 trial · 1 indication
GFR measured by the Iohexol plasma clearance technique
24-hour urinary protein excretion will be measured as median of three measurements in three consecutive 24-hour urine collections
| Arm | Type | Description |
|---|---|---|
| IMP | EXPERIMENTAL | Dapagliflozin 10 mg/die will be administered orally for six-weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo, one tablet/die will be administered orally for six-weeks. |
| Name | Type | Description |
|---|---|---|
| Dapagliflozin 10Mg Tab | DRUG | Dapagliflozin 10 mg/die will be administered orally for six-weeks. |
| Placebo | OTHER | Placebo one tablet/die will be administered orally for six-weeks. |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Male or female more than 18 year old 3. Non-diabetic Stage-IV CKD 4. Fasting blood glucose ≤ 125 mg (≤ 6.9 mmol/l) and HbA1C ≤6.4% (≤ 47 mmol/mol)58 without treatment with oral blood glucose lowering medi...