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AzTrials

Contrast Enhancement in Magnetic Resonance ImagingPhase 1NCT05061979

A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function

A Phase 1 study testing BAY1747846 in people with Contrast Enhancement in Magnetic Resonance Imaging, run by Bayer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers in this study want to learn how a new contrast agent for magnetic resonance imaging (MRI) called BAY1747846 moves into, through and out of the body (pharmacokinetics) after injection in participants with normal and impaired renal function. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
What is being tested?
BAY1747846
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
12 Oct 2021to 14 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent
  • Renally Impaired Participants and Disease Characteristics
  • Mildly or moderately decreased renal function, as assessed by estimated glomerular filtration rate (eGFR). Mildly impaired renal function: eGFR: 60 up to 89 mL/min/1.73 m^2 (inclusive); Moderately impaired renal function: eGFR: 30 up to 59 mL/min/1.73 m^2 (inclusive)
  • Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening
  • Participants with normal renal function: Normal renal function, as assessed by eGFR ≥90 mL/min/1.73 m^2
  • Body mass index (BMI) within the range 18 - 40 kg/m^2 (inclusive)
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  • Body weight (bw) ≥ 45 kg
  • Study participants of reproductive potential must agree to use adequate contraception when sexually active.
  • Male participants must agree not to donate sperm from the signing of the ICF until the follow-up visit on Day 12 (± 2d).

Who cannot join

  • Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment
  • Acute renal failure or acute nephritis within the past 2 years
  • Febrile illness within 1 week before study drug administration
  • Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
  • Conditions associated with a risk of hypersensitivity reactions as judged by the investigator
  • Any participant not able to produce urine and/or needing dialysis
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  • Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention
  • Contrast agent administration within one month prior to screening or during the screening period
  • Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to administration of study intervention
  • Clinically relevant abnormalities in physical examination, ECG, clinical chemistry, hematology, or urinalysis as judged by the investigator
  • Heart rate below 45 bpm or above 110 bpm
  • Systolic blood pressure below 90 mmHg or above 170 mmHg
  • Diastolic blood pressure below 45 or above 105 mmHg
  • Indication or evidence for long QT syndrome for all participants; additionally for participants with normal renal function: QT interval corrected using Fridericia's method (QTcF) > 470 msec
  • History of COVID-19 within 6 months prior to screening
  • Long COVID-19 syndrome or other clinically relevant COVID-19-related symptoms or sequela
  • Incomplete SARS-CoV-2 vaccination
  • Vaccination planned before completion of the last study visit

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Alliance for Multispecialty Research, LLC - Knoxville

    Knoxville, Tennessee, 37920

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33014

Other trials in United States

About this study

Official title: Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of BAY1747846 in Participants With Impaired Renal Function in Comparison to Matched Participants With Normal Renal Function

Researchers in this study want to learn how a new contrast agent for magnetic resonance imaging (MRI) called BAY1747846 moves into, through and out of the body (pharmacokinetics) after injection in participants with normal and impaired renal function. Impaired renal function is a condition where the kidneys do not work as well as they should.

BAY1747846 belongs to the class gadolinium-based contrast agents (GBCAs). The way the body removes GBCAs including BAY1747846 from the blood is through the kidneys. So, when the kidneys are not working normally, it takes longer to remove BAY1747846 out of the body.

Read more

The participants in this study will either have normal renal function, or will have mild or moderate impaired renal function. The participants will receive BAY1747846 one time through a needle into a vein.

During the study, the participants will visit the study site about 6 times. The participants will stay at the study site for up to 9 days. Each participant will be in the study for up to 7 months. During the study, the doctors will:

  • check the participants' overall health
  • take blood and urine samples
  • ask the participants about what medications they are taking and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Being tested
BAY1747846

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1747846Drug

    Solution for intravenous (IV) injection, single dose

Study groups in NCT05061979
Study groupRoleWhat they receive
Mild renal impairmentExperimentalParticipants with mild renal impairment will receive a single dose of BAY1747846.
Receives: Drug: BAY1747846
Moderate renal impairmentExperimentalParticipants with moderate renal impairment will receive a single dose of BAY1747846.
Receives: Drug: BAY1747846
Normal renal functionExperimentalParticipants with normal renal function will receive a single dose of BAY1747846.
Receives: Drug: BAY1747846

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration versus time curve from zero to infinity of BAY1747846 after single dose administration (AUC)

    Measured: Pre-dose until 7 days post-dose

  2. Maximum observed drug concentration of BAY1747846 in plasma after single dose administration (Cmax)

    Measured: Pre-dose until 7 days post-dose

  3. Total body clearance of BAY1747846 normalized by body weight

    Measured: Pre-dose until 7 days post-dose

Secondary outcomes (2)

  1. Number of participants with treatment-emergent adverse events

    Measured: After administration of study intervention up to Day 12 (± 2 days)

  2. Number of participants with treatment-emergent adverse events categorized by severity

    Measured: After administration of study intervention up to Day 12 (± 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2021
  2. Study start12 Oct 2021
  3. Primary completion16 Mar 2022
  4. Study completion14 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05061979
Sponsor's protocol ID
21180
Status last verified
Nov 2022
First submitted
21 Sep 2021
Last updated
21 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Publications

  • Fadini T, Sutter G, Klein S, Busemann E, Vendel E, Vis P, Heitmeier S, Frenzel T, Ebert W, Hofmann BM. Pharmacokinetics, Safety, and Dialyzability of Gadoquatrane in Patients With Impaired Renal Function: A Comprehensive Investigation Using Clinical Trial Data, Modeling and Simulation, and In Vitro Data. Invest Radiol. 2025 Nov 1;60(11):779-790. doi: 10.1097/RLI.0000000000001191.

    PubMed 40215351

  • Lohrke J, Berger M, Frenzel T, Hilger CS, Jost G, Panknin O, Bauser M, Ebert W, Pietsch H. Preclinical Profile of Gadoquatrane: A Novel Tetrameric, Macrocyclic High Relaxivity Gadolinium-Based Contrast Agent. Invest Radiol. 2022 Oct 1;57(10):629-638. doi: 10.1097/RLI.0000000000000889. Epub 2022 Jun 13.

    PubMed 35703267

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1747846 in people with Contrast Enhancement in Magnetic Resonance Imaging, run by Bayer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration versus time curve from zero to infinity of BAY1747846 after single dose administration (AUC) (time frame: Pre-dose until 7 days post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05061979, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.

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