| Trial ID: | L0533 |
| Source ID: | NCT04243850
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
REGROUP: Renohemodynamic Effects empaGliflozin in vaRiOUs Populations
|
| Acronym: |
REGROUP
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Chronic Kidney Diseases
|
| Interventions: |
DRUG: Empagliflozin 10 MG|DRUG: Placebo oral tablet|DIAGNOSTIC_TEST: Caffeine
|
| Outcome Measures: |
Primary: measured glomerulair filtration rate (mGFR), using iohexol, 7 days | Secondary: effective renal plasma flow, as part of renal hemodynamics, 7 days|renal vascular resistance, as part of renal hemodynamics, 7 days|Caffeine-induced changes in renal hemodynamics, to investigate whether the observed changes are adenosine dependent, 7 days|proximal sodium excretion, using fractional excretion of lithium as a surrogate of proximal sodium handling, 7 days
|
| Sponsor/Collaborators: |
Sponsor: Amsterdam UMC, location VUmc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-07-01
|
| Completion Date: |
2022-03-01
|
| Results First Posted: |
|
| Last Update Posted: |
2021-10-08
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04243850
|
