| Trial ID: | L4710 |
| Source ID: | NCT04238702
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
Renohemodynamic Effects of Combined empagliflOzin and LosARtan
|
| Acronym: |
RECOLAR
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Diabetic Kidney Disease
|
| Interventions: |
DRUG: Empagliflozin 10 MG|DRUG: Losartan 50Mg Tab|OTHER: Placebo
|
| Outcome Measures: |
Primary: Glomerular Filtration Rate (GFR), change in mGFR after 7 days of treatment using iohexol, 7 days|Effective Renal Plasma Flow (ERPF), change in ERPF after 7 days of treatment using iohexol, 7 days | Secondary: Glomerular Hydrostatic Pressure, glomerular hydrostatic pressure which will be assessed by the Gomez formulae, 7 days|Arteriolar resistance, arteriolar resistance which will be assessed by the Gomez formulae, 7 days|Renal tubular function, Elektrolytes in urine, 7 days|GFR trajectory, Creatinine clearance, 7 days|Systemic hemodynamics, Bloodpressure, 7 days|Autonomic nervous system activity, Heart rate variability, 7 days|Vascular function, Arterial stiffness (Pulse Wave Analysis), 7 days
|
| Sponsor/Collaborators: |
Sponsor: Amsterdam UMC, location VUmc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-11-04
|
| Completion Date: |
2021-09-27
|
| Results First Posted: |
|
| Last Update Posted: |
2021-10-08
|
| Locations: |
VU University Medical Center, Amsterdam, Noord-Holland, 1081HV, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT04238702
|
