Clinical Trial Details
| Trial ID: | L0057 |
| Source ID: | NCT04794517 |
| Associated Drug: | Dapagliflozin 10mg Tab |
| Title: | Dapagliflozin in Non-diabetic Stage IV CKD |
| Acronym: | ADAPT |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Diseases |
| Interventions: | DRUG: Dapagliflozin 10Mg Tab|OTHER: Placebo |
| Outcome Measures: | Primary: Glomerular Filtration rate (GFR), GFR measured by the Iohexol plasma clearance technique, Changes from baseline and day 1, 8, 42,84, 92,126 and 140.|24-hour urinary protein excretion, 24-hour urinary protein excretion will be measured as median of three measurements in three consecutive 24-hour urine collections, Changes from start (day 0, day 84) and end (day 42, day 126) of each Treatment Period with dapagliflozin or placebo | Secondary: Renal plasma flow (RPF), RPF will be assessed by the Para Amino Hippuric (PAH) plasma clearance technique., Changes from baseline and day 1, 8, 42,84, 92,126 and 140. |
| Sponsor/Collaborators: | Sponsor: Mario Negri Institute for Pharmacological Research | Collaborators: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 32 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2021-11-08 |
| Completion Date: | 2024-05-07 |
| Results First Posted: | |
| Last Update Posted: | 2024-05-10 |
| Locations: | Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò", Ranica, BG, 24020, Italy |
| URL: | https://clinicaltrials.gov/show/NCT04794517 |
