Chronic Kidney DiseasePhase 1NCT04820621
Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment
A Phase 1 study testing Runcaciguat (BAY1101042) in people with Chronic Kidney Disease, run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the drug in the body. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Runcaciguat (BAY1101042)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 7 Apr 2021to 1 Jul 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age
- Participant must be 18 to 79 years of age (inclusive) at the time of signing the informed consent.
- Weight
- Body mass index (BMI) within the range 18 to 35 kg/m^2 (inclusive). Sex and Contraceptive/Barrier Requirements
- Male and female white participants. Main Inclusion Criteria for participants with hepatic impairment
- Participants with hepatic impairment (Child Pugh A or B).
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- Participants with stable liver disease in the last 2 months. Main Inclusion Criteria for control group of participants
- Healthy male and female white participants.
- Mean age and body weight in the control group and in the two groups with hepatic impairment (Child Pugh A and B) should not vary by more than ±10 years and ±10 kg.
- Gender-matched.
Who cannot join
- Main exclusion Criteria for all participants Medical and surgical history
- Participants with a medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the sponsor.
- Medication, drug use and special behavioral patterns
- Suspicion of drug or alcohol abuse. Other
- Participation in another clinical trial within 3 months (for previous multi-dose study) or 1 month (for previous single dose study) before dosing.
- Exclusion periods from other studies or simultaneous participation in other clinical studies.
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- coronavirus disease 2019 (COVID-19) specific exclusion criteria
- History of COVID-19.
- Contact with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) positive or COVID-19 patient within the last 4 weeks prior to admission to the clinical unit
- Positive SARS-CoV-2 viral polymerase chain reaction (PCR) test
- Main exclusion Criteria for participants with hepatic impairment Medical and surgical history
- Pre-existing diseases beside hepatic impairment for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Evidence of hepatic encephalopathy related to chronic liver disease > grade 2 (exclusion by Number Connection Test).
- Congestive heart failure of New York Heart Association grade III or IV.
- History of conspicuous bleeding within the past 3 months.
- Severe arrhythmia requiring antiarrhythmic treatment within the past 3 months.
- Participants with diabetes mellitus with a glycohemoglobin A1c (HbA1c) >9%.
- Severe ascites of more than 6 L (estimated by ultrasound).
- Participants with primary and secondary biliary cirrhosis.
- Participants with sclerosing cholangitis. Electrocardiogramm (ECG), blood pressure, heart rate
- Systolic blood pressure below 100 mmHg or above 169 mmHg.
- Diastolic blood pressure below 50 and above 95 mmHg.
- Resting heart rate below 50 beats per minute (bpm) or above 95 bpm. Laboratory examination
- Platelet count < 40 x 10^9/L.
- Hemoglobin <9 g/dL.
- Alkaline phosphatase (AP) ≥ 4 times the upper limit of normal (ULN).
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in conjunction with gamma glutamyl transpeptidase (GGT) ≥4 times the ULN (an isolated elevation of GGT above 4 times ULN will not exclude the participant).
- Serum albumin <20 g/L.
- Prothrombin time (Quick test) <40%.
- Renal failure with an estimated glomerular filtration rate (eGFR) ≤ 40 mL/min/1.73 m^2 (according to CKD-EPI equation).
- Main Exclusion criteria for control group of participants Medical and surgical history
- A history of relevant diseases of vital organs, the central nervous system, or other organs.
- Liver insufficiency or active liver disease, which may include unexplained persistent transaminase elevations.
- Renal impairment with an estimated glomerular filtration rate (eGFR) ≤80 mL/min/1.73 m^2 (according to CKD-EPI equation).
- Known or suspected liver disorders (e.g. Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis, also history of it).
- Medication, drug use and special behavioral patterns
- Regular use of therapeutic or recreational drugs, e.g. carnitin products, anabolics, high dose vitamins.
- Laboratory examination
- Relevant deviation from the normal range in clinical chemistry (including thyroid stimulating hormone [TSH]), hematology, coagulation or urinalysis as judged by the investigator.
- Increase of liver enzymes (e.g. ALT, AST, alkaline phosphatase, gamma glutamyl transpeptidase or total bilirubin) above ULN.
- Increase of lipase and amylase (despite isolated marginal increases of lipase or amylase to account for variability of the parameters, and the participant is asymptomatic and has no other laboratory changes assuming disease based on medical judgment).
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus (HIV) antibodies 1+2/HIV p24 antigen (HIV-1/2 combi test).
- Electrocardiogramm (ECG), blood pressure heart rate
- Systolic blood pressure below 100 or above 145 mmHg at screening.
- Diastolic blood pressure below 50 or above 95 mmHg at screening.
- Resting heart rate below 50 or above 95 bpm at screening.
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Investigation of the Pharmacokinetics, Safety and Tolerability of Runcaciguat in Participants With Hepatic Impairment (Classified as Child Pugh A or B) and in a Control Group of Age-, Weight-, and Gender-matched Participants Following a Single Oral 15 mg Modified Release (MR) Tablet Dose in a Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
Researchers are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the drug in the body.
In this study researchers will investigate how the liver function influences blood concentrations of runcaciguat in participants with different degrees of liver impairment compared to participants with normal liver function.
Read more
The participants will all take one tablet with 15 mg runcaciguat by mouth. Prior to inclusion into the study, all participants will have a screening examination within 21 to 2 days prior to dosing to check eligibility for study participation.
During the study, all of the participants will stay at the study site for up to 8 days (from Day -1 to Day 7), whereby Day 6 and 7 might also be performed in an ambulatory setting. Blood and urine samples will be collected. The physician will check the participants' heart health using an electrocardiogram (ECG) and by measuring blood pressure and heart rate. The participants will answer questions about their wellbeing and taken medications.
The participants will have a follow-up examination 7 to 11 days after dosing to follow-up their health.
Each participant will be in the study for approximately 5 weeks. The entire study will last about 9 months.
- Conditions
- Chronic Kidney Disease
- Being tested
- Runcaciguat (BAY1101042)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Runcaciguat (BAY1101042)Drug
Given as 1 x 15 mg modified release [MR] tablet
| Study group | Role | What they receive |
|---|---|---|
| Participants with mild hepatic impairment | Experimental | All participants will receive a single oral dose in the fasted state on Day 1. Receives: Drug: Runcaciguat (BAY1101042) |
| Participants with moderate hepatic impairment | Experimental | All participants will receive a single oral dose in the fasted state on Day 1. Receives: Drug: Runcaciguat (BAY1101042) |
| Participants with normal hepatic function | Experimental | All participants will receive a single oral dose in the fasted state on Day 1. Receives: Drug: Runcaciguat (BAY1101042) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042
AUC(0-tlast) will be used as main parameters if mean AUC(tlast - ∞) >20% of AUC
Measured: From dosing day (Day 1) up to 12 days post dose
Unbound AUC (AUCu) of BAY1001042
AUC(0-tlast)u will be used as main parameters if mean AUC(tlast - ∞) >20% of AUC
Measured: From dosing day (Day 1) up to 12 days post dose
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1001042
Measured: From dosing day (Day 1) up to 12 days post dose
Unbound Cmax (Cmax,u) of BAY1001042
Measured: From dosing day (Day 1) up to 12 days post dose
Secondary outcomes (1)
Numbers of participants with treatment-emergent adverse events (TEAEs) and study intervention related TEAE
Measured: From start of treatment up to 10 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start7 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: This study is prematurely terminated due to changes in sponsor's overall development strategy. The decision of termination is not related to any safety concern of the compound.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820621
- Sponsor's protocol ID
- 19620
- Other IDs
- 2020-005716-22
- Status last verified
- Jul 2021
- First submitted
- 26 Mar 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Pharmacokinetics, Safety and Tolerability of Runcaciguat in Participants With Hepatic Impairment (Classified as Child Pugh A or B) and in a Control Group of Age-, Weight-, and Gender-matched Participants Following a Single Oral 15 mg Modified Release (MR) Tablet Dose in a Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
- ClinicalTrials.gov ID
- NCT04820621
- Acronym / sponsor ID
- 19620
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is prematurely terminated due to changes in sponsor's overall development strategy. The decision of termination is not related to any safety concern of the compound.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 Mar 2021 (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 are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the drug in the body.
In this study researchers will investigate how the liver function influences blood concentrations of runcaciguat in participants with different degrees of liver impairment compared to participants with normal liver function.
The participants will all take one tablet with 15 mg runcaciguat by mouth. Prior to inclusion into the study, all participants will have a screening examination within 21 to 2 days prior to dosing to check eligibility for study participation.
During the study, all of the participants will stay at the study site for up to 8 days (from Day -1 to Day 7), whereby Day 6 and 7 might also be performed in an ambulatory setting. Blood and urine samples will be collected. The physician will check the participants' heart health using an electrocardiogram (ECG) and by measuring blood pressure and heart rate. The participants will answer questions about their wellbeing and taken medications.
The participants will have a follow-up examination 7 to 11 days after dosing to follow-up their health.
Each participant will be in the study for approximately 5 weeks. The entire study will last about 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with mild hepatic impairment | Experimental | Drug: Runcaciguat (BAY1101042)All participants will receive a single oral dose in the fasted state on Day 1. |
| Participants with moderate hepatic impairment | Experimental | Drug: Runcaciguat (BAY1101042)All participants will receive a single oral dose in the fasted state on Day 1. |
| Participants with normal hepatic function | Experimental | Drug: Runcaciguat (BAY1101042)All participants will receive a single oral dose in the fasted state on Day 1. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age
- Participant must be 18 to 79 years of age (inclusive) at the time of signing the informed consent.
- Weight
- Body mass index (BMI) within the range 18 to 35 kg/m^2 (inclusive). Sex and Contraceptive/Barrier Requirements
- Male and female white participants. Main Inclusion Criteria for participants with hepatic impairment
Key exclusion criteria (46 listed)
- Main exclusion Criteria for all participants Medical and surgical history
- Participants with a medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the sponsor.
- Medication, drug use and special behavioral patterns
- Suspicion of drug or alcohol abuse. Other
- Participation in another clinical trial within 3 months (for previous multi-dose study) or 1 month (for previous single dose study) before dosing.
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 |
|---|---|---|
| Runcaciguat (BAY1101042)Given as 1 x 15 mg modified release [MR] tablet | Drug | Participants with mild hepatic impairment, Participants with moderate hepatic impairment, Participants with normal hepatic function |
Primary outcome
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042
Time frame: From dosing day (Day 1) up to 12 days post dose
AUC(0-tlast) will be used as main parameters if mean AUC(tlast - ∞) >20% of AUC
Unbound AUC (AUCu) of BAY1001042
Time frame: From dosing day (Day 1) up to 12 days post dose
AUC(0-tlast)u will be used as main parameters if mean AUC(tlast - ∞) >20% of AUC
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1001042
Time frame: From dosing day (Day 1) up to 12 days post dose
Unbound Cmax (Cmax,u) of BAY1001042
Time frame: From dosing day (Day 1) up to 12 days post dose
1 secondary outcome
Numbers of participants with treatment-emergent adverse events (TEAEs) and study intervention related TEAE
Time frame: From start of treatment up to 10 days after the treatment
Results and safety
The study was stopped early (reason given: This study is prematurely terminated due to changes in sponsor's overall development strategy. The decision of termination is not related to any safety concern of the compound.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: 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.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 Runcaciguat (BAY1101042) in people with Chronic Kidney Disease, run by Bayer at 1 site in Germany.
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 10 inclusion and 46 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 15 Jul 2021. 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 Germany. 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: This study is prematurely terminated due to changes in sponsor's overall development strategy. The decision of termination is not related to any safety concern of the compound.). 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?
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042 (time frame: From dosing day (Day 1) up to 12 days post dose). The study lists 4 primary outcomes in all. 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 15 Jul 2021.