Moderate Chronic Kidney DiseasePhase 1NCT04552262
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
A Phase 1 study testing BAY2327949 in people with Moderate Chronic Kidney Disease, run by Bayer at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate Chronic Kidney Disease
- What is being tested?
- BAY2327949
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Sep 2020to 5 May 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent
- Clinical diagnosis of CKD for at least 6 months, with eGFR ≥30 mL/min/1.73 m2 but <60 mL/min/1.73 m2 (eGFR will be estimated at study site from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- Copeptin level of ≥10 pmol/L at the screening visit
- Men or confirmed postmenopausal women (documented by medical report verification and defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone [FSH] levels >40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
- Sexually active men, who have not been surgically sterilized, must agree to use 2 reliable and acceptable methods of contraception simultaneously (whereby one method has to be applied in the man and one method in the female partner), and not to act as sperm donor. This applies for the time period between signing of the informed consent form (ICF) and 12 weeks after the last administration of study drug.
- Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
- Participants must be able to meet the requirements of the MRI scan (e.g. physically able to fit into the scanner)
- If patient is taking loop diuretics, must be able to discontinue loop diuretics in the morning of Visit 2 and Visit 3.
Who cannot join
- Known acute kidney diseases (incl. kidney stones) or renal conditions that in the opinion of the investigator are expected to significantly change in intensity over the study period
- Clinical diagnoses of heart failure and persistent symptoms (New York Heart Association class III - IV)
- Systolic blood pressure >160 mmHg, or diastolic blood pressure ≥100 mmHg
- Stroke, transient ischemic cerebral attack, acute coronary syndrome, hospitalization for worsening heart failure or unplanned/emergency hospitalization in the last 3 months prior to randomization
- Renal allograft in place
- Hepatic insufficiency classified as Child-Pugh B or C, or active hepatitis B or C at Visit 1.
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- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin
- Dialysis for acute renal failure within the previous 6 months prior to randomization
- Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to randomization
- Participant is taking concomitant medication that is:
- - A moderate or strong inhibitor of cytochrome P450 (CYP)3A
- - A moderate or strong inducer of CYP3A
- - A moderate or strong inhibitor of P-glycoprotein transport
- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study intervention
- Previous (i.e. within 3 months prior to randomization) or concomitant participation in another clinical study with the study intervention
- Body mass index (BMI) >35 kg/m²
- Body weight exceeding 120 kg
- Glycosylated hemoglobin (HbA1c) >11% at Visit 1
- History or suggestive of alcohol or substance abuse
- Planned change in dose or schedule of concomitant medication within 4 weeks prior to Visit 1, or planned change during the time course of this study
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
- Any other conditions which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant's participation in or completion of the study
- Close affiliation of the participant with the investigational site, e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
- Participant is in custody by order of an authority or court of law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Moderate Chronic Kidney Disease
- Being tested
- BAY2327949, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2327949Drug
Single dose of 90 mg BAY2327949
PlaceboDrug
Single dose of placebo to BAY 2327949
| Study group | Role | What they receive |
|---|---|---|
| BAY2327949 / Placebo | Experimental | Each participant will receive two treatments: a single dose of 90 mg BAY 2327949 (Treatment A) and a single dose of placebo to BAY 2327949 (Treatment B), with a washout period of at least 7 days before the second treatment. Receives: Drug: BAY2327949 |
| Placebo / BAY2327949 | Experimental | Each participant will receive two treatments: a single dose of 90 mg BAY 2327949 (Treatment A) and a single dose of placebo to BAY 2327949 (Treatment B), with a washout period of at least 7 days before the second treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 2 hours of treatment
Secondary outcomes (6)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 2 hours of treatment
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start30 Sep 2020
- Primary completion21 Dec 2020
- Study completion5 May 2021
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552262
- Sponsor's protocol ID
- 19748
- Other IDs
- 2019-003569-17, 2019
- Status last verified
- Aug 2022
- First submitted
- 11 Sep 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04552262
- Acronym / sponsor ID
- 19748
- Conditions
- Moderate Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY2327949 / Placebo | Experimental | Drug: BAY2327949Each participant will receive two treatments: a single dose of 90 mg BAY 2327949 (Treatment A) and a single dose of placebo to BAY 2327949 (Treatment B), with a washout period of at least 7 days before the second treatment. |
| Placebo / BAY2327949 | Experimental | Drug: PlaceboEach participant will receive two treatments: a single dose of 90 mg BAY 2327949 (Treatment A) and a single dose of placebo to BAY 2327949 (Treatment B), with a washout period of at least 7 days before the second treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent
- Clinical diagnosis of CKD for at least 6 months, with eGFR ≥30 mL/min/1.73 m2 but <60 mL/min/1.73 m2 (eGFR will be estimated at study site from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- Copeptin level of ≥10 pmol/L at the screening visit
- Men or confirmed postmenopausal women (documented by medical report verification and defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone [FSH] levels >40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
- Sexually active men, who have not been surgically sterilized, must agree to use 2 reliable and acceptable methods of contraception simultaneously (whereby one method has to be applied in the man and one method in the female partner), and not to act as sperm donor. This applies for the time period between signing of the informed consent form (ICF) and 12 weeks after the last administration of study drug.
Key exclusion criteria (24 listed)
- Known acute kidney diseases (incl. kidney stones) or renal conditions that in the opinion of the investigator are expected to significantly change in intensity over the study period
- Clinical diagnoses of heart failure and persistent symptoms (New York Heart Association class III - IV)
- Systolic blood pressure >160 mmHg, or diastolic blood pressure ≥100 mmHg
- Stroke, transient ischemic cerebral attack, acute coronary syndrome, hospitalization for worsening heart failure or unplanned/emergency hospitalization in the last 3 months prior to randomization
- Renal allograft in place
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY2327949Single dose of 90 mg BAY2327949 | Drug | BAY2327949 / Placebo |
| PlaceboSingle dose of placebo to BAY 2327949 | Drug | Placebo / BAY2327949 |
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)
Time frame: Within 2 hours of treatment
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
6 secondary outcomes
Difference between T1 (renal water content) after administration of BAY 2327949 and placebo
Time frame: Within 2 hours of treatment
Difference between T2* in the kidney cortex after administration of BAY 2327949 and placebo
Time frame: Within 2 hours of treatment
Difference between T2* in the kidney medulla after administration of BAY 2327949 and placebo
Time frame: Within 2 hours of treatment
Difference between renal cortical perfusion after administration of BAY 2327949 and placebo
Time frame: Within 2 hours of treatment
Difference between renal arterial flow after administration of BAY 2327949 and placebo
Time frame: Within 2 hours of treatment
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 21 days
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2327949 in people with Moderate Chronic Kidney Disease, run by Bayer at 1 site in Denmark.
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 8 inclusion and 24 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: stopped early, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 was stopped early (reason given: Terminated). Results are not available in the source record.
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?
Difference between renal medullary perfusion after administration of BAY 2327949 and placebo as assessed by arterial spin labelling magnetic resonance imaging (ASL-MRI) (time frame: Within 2 hours of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2022.