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Clinical Trial Details

Trial ID: L0365
Source ID: NCT04552262
Associated Drug: Bay2327949
Title: Study to Learn More About the Effect of a New Drug Called BAY2327949 on the Blood Flow Through Kidneys in Adult Participants With Moderate Chronic Kidney Disease
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Moderate Chronic Kidney Disease
Interventions: DRUG: BAY2327949|DRUG: Placebo
Outcome Measures: Primary: Difference between renal medullary perfusion after administration of BAY 2327949 and placebo as assessed by arterial spin labelling magnetic resonance imaging (ASL-MRI), 2-way crossover design Participants Arm 1: Single dose of BAY2327949 + 7 days washout phase + Single dose of Placebo Participants Arm 2: Single dose of Placebo + 7 days washout phase + Single dose of BAY2327949, Within 2 hours of treatment | Secondary: Difference between T1 (renal water content) after administration of BAY 2327949 and placebo, 2-way crossover design Participants Arm 1: Single dose of BAY2327949 + 7 days washout phase + Single dose of Placebo Participants Arm 2: Single dose of Placebo + 7 days washout phase + Single dose of BAY2327949 T1 = (renal water content) (unit: ms) acquired during MRI scanning (this parameter will only be obtained at two timepoints, baseline and after the perfusion assessments, and not for all multimodal MRI assessments), Within 2 hours of treatment|Difference between T2* in the kidney cortex after administration of BAY 2327949 and placebo, 2-way crossover design Participants Arm 1: Single dose of BAY2327949 + 7 days washout phase + Single dose of Placebo Participants Arm 2: Single dose of Placebo + 7 days washout phase + Single dose of BAY2327949 T2 = (unit: ms) acquired during MRI scanning, Within 2 hours of treatment|Difference between T2* in the kidney medulla after administration of BAY 2327949 and placebo, 2-way crossover design Participants Arm 1: Single dose of BAY2327949 + 7 days washout phase + Single dose of Placebo Participants Arm 2: Single dose of Placebo + 7 days washout phase + Single dose of BAY2327949 T2 = (unit: ms) acquired during MRI scanning, Within 2 hours of treatment|Difference between renal cortical perfusion after administration of BAY 2327949 and placebo, 2-way crossover design Participants Arm 1: Single dose of BAY2327949 + 7 days washout phase + Single dose of Placebo Participants Arm 2: Single dose of Placebo + 7 days washout phase + Single dose of BAY2327949, Within 2 hours of treatment|Difference between renal arterial flow after administration of BAY 2327949 and placebo, 2-way crossover design Participants Arm 1: Single dose of BAY2327949 + 7 days washout phase + Single dose of Placebo Participants Arm 2: Single dose of Placebo + 7 days washout phase + Single dose of BAY2327949, Within 2 hours of treatment|Number of participants with treatment-emergent adverse events (TEAEs), Up to 21 days
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 7
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-09-30
Completion Date: 2021-05-05
Results First Posted:
Last Update Posted: 2022-08-23
Locations: Steno Diabetes Center Copenhagen, Herlev, 2730, Denmark
URL: https://clinicaltrials.gov/show/NCT04552262