stop_circleTerminated/Withdrawn

Moderate chronic kidney disease

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

Trial purpose

Researchers in this study want to learn more about the effect of a new drug called BAY2327949 on the blood flow through kidneys in adult participants with moderate long lasting kidney disease. It is thought that, in long lasting kidney disease, blood flow through the kidney tissue is changed, and that some parts of the kidney may receive less oxygen and nutrients because of this. BAY2327949 is a new drug under development with a goal to modify how much blood is flowing through kidneys. It works by binding to and blocking proteins that can regulate blood flow through the kidneys.
Participants in this study will receive 3 tablets of BAY2327949 once and 3 tablets of Placebo once (a placebo looks like a drug but does not have any medicine in it). Both BAY2327949 and Placebo will be taken orally. And after taking each of them, participants will undergo a Magnetic Resonance Imaging (MRI) scanning for 60 to 90 minutes to assess the blood flow to kidneys. MRI is an examination of parts of the body (in this case the kidney) which provides images of these regions. Blood samples will be collected from the participants to check the general health and look at how the study drug is working in the body and how the body affects the study drug. Participants will visit the hospital or clinic about 4 times in total, and the observation for each participant will not more than 56 days.

Key Participants Requirements

Sex

All

Age

18 - 75 Years

Trial summary

Enrollment Goal
7
Trial Dates
September 2020 - May 2021
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY2327949
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Steno Diabetes Center CopenhagenHerlev, 2730, Denmark
Withdrawn
Glostrup HospitalGlostrup, 2600, Denmark

Primary Outcome

  • 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
    date_rangeTime Frame:
    Within 2 hours of treatment

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Within 2 hours of treatment
  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 21 days

Trial design

A randomized, 2-way crossover, placebo-controlled, double-blind study to evaluate effects of single oral doses of BAY 2327949 on renal perfusion in participants with moderate chronic kidney disease
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2