Renal DialysisPhase 1NCT03787368
End-stage Renal Disease (ESRD) Pilot Study
A Phase 1 study testing BAY1213790 and 0.9% sodium chloride solution in people with Renal Dialysis, run by Bayer at 15 sites in 4 countries.
Trial summary
The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- BAY1213790 and 0.9% sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 31 Jan 2019to 15 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 80 years of age.
- ESRD on hemodialysis (including hemodiafiltration) for at least 3 months
- Life expectancy of > 6 months
- Women of non-childbearing potential
Who cannot join
- High risk for clinically significant bleeding
- Acute renal failure
- Planned major surgery in the next 7 months from randomization
- Concomitant use of oral anticoagulant therapy or antiplatelet therapy
- Documented thrombotic event in the past 6 months
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Spain5 sites
Hospital Reina Sofía
Córdoba, 14004
Ciutat Sanitària i Universitària de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Universitario Dr. Peset
Valencia, 46017
United States4 sites
Nova Clinical Research, LLC
Bradenton, Florida, 34209
Research by Design, LLC
Chicago, Illinois, 60643
California Institute of Renal Research - Chula Vista
Chula Vista, California, 91910
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, 01107
Belgium3 sites
UZ Brussel
Bruxelles - Brussel, 1090
UZ Leuven Gasthuisberg
Leuven, 3000
CHU de Charleroi Hôpital civil
Lodelinsart, Hainaut, 6042
Portugal3 sites
CHLO - Hospital Santa Cruz
Carnaxide, Lisbon District, 2795-53
Pluribus Dialise - Cascais (DaVita)
Cascais, Lisbon District, 2750-663
CHMT - Hospital Rainha Santa Isabel
Torres Novas, Santarém District, 2350-754
About this study
Official title: An Observer-blind, Multi-center, Placebo-controlled, Parallel Group Study to Assess the Safety and Tolerability and to Characterize the Pharmacokinetics and the Pharmacodynamics of Different Doses of BAY1213790 in Patients With End-stage Renal Disease Undergoing Hemodialysis
The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study.
- Conditions
- Renal Dialysis
- Being tested
- BAY1213790, 0.9% sodium chloride solution
- Keywords
- End-stage renal disease patients undergoing hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1213790Drug
Single intravenous infusion of BAY1213790 (Two different doses)
0.9% sodium chloride solutionDrug
Single intravenous infusion of Placebo (0.9% sodium chloride solution)
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of BAY1213790 | Experimental | Single intravenous infusion BAY1213790 (Dose 1) Receives: Drug: BAY1213790 |
| Dose 2 of BAY1213790 | Experimental | Single intravenous infusion BAY1213790 (Dose 2) Receives: Drug: BAY1213790 |
| Placebo | Placebo comparator | Single intravenous infusion placebo Receives: Drug: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major and CRNM bleeding events
CRNM bleeding: Clinically Relevant Non-Major bleeding
Measured: Approx. 4 weeks (Before study drug or placebo administration)
Number of major and CRNM bleeding events
Measured: Approx. 4 weeks (After study drug or placebo administration)
Secondary outcomes (3)
AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
Measured: Approx. 5 months (Pre-dose to follow up)
aPTT will be measured via the kaolin-trigger method (clotting assay)
aPTT: activated Partial Thromboplastin Time
Measured: Approx. 6 months (Before study drug or placebo administration to follow up)
Factor XI activity will be assessed with an aPTT-based coagulation test using FXI
FXI: Factor XI
Measured: Approx. 6 months (Before study drug or placebo administration to follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start31 Jan 2019
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787368
- Sponsor's protocol ID
- 20046
- Other IDs
- 2018-003109-24, 2018
- Status last verified
- Mar 2022
- First submitted
- 24 Dec 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blind, Multi-center, Placebo-controlled, Parallel Group Study to Assess the Safety and Tolerability and to Characterize the Pharmacokinetics and the Pharmacodynamics of Different Doses of BAY1213790 in Patients With End-stage Renal Disease Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT03787368
- Acronym / sponsor ID
- 20046
- Conditions
- Renal Dialysis
- Keywords
- End-stage renal disease patients undergoing hemodialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 26 Dec 2018 (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.
The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 of BAY1213790 | Experimental | Drug: BAY1213790Single intravenous infusion BAY1213790 (Dose 1) |
| Dose 2 of BAY1213790 | Experimental | Drug: BAY1213790Single intravenous infusion BAY1213790 (Dose 2) |
| Placebo | Placebo comparator | Drug: 0.9% sodium chloride solutionSingle intravenous infusion placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients between 18 and 80 years of age.
- ESRD on hemodialysis (including hemodiafiltration) for at least 3 months
- Life expectancy of > 6 months
- Women of non-childbearing potential
Key exclusion criteria (5 listed)
- High risk for clinically significant bleeding
- Acute renal failure
- Planned major surgery in the next 7 months from randomization
- Concomitant use of oral anticoagulant therapy or antiplatelet therapy
- Documented thrombotic event in the past 6 months
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 |
|---|---|---|
| BAY1213790Single intravenous infusion of BAY1213790 (Two different doses) | Drug | Dose 1 of BAY1213790, Dose 2 of BAY1213790 |
| 0.9% sodium chloride solutionSingle intravenous infusion of Placebo (0.9% sodium chloride solution) | Drug | Placebo |
Primary outcome
Number of major and CRNM bleeding events
Time frame: Approx. 4 weeks (Before study drug or placebo administration)
CRNM bleeding: Clinically Relevant Non-Major bleeding
Number of major and CRNM bleeding events
Time frame: Approx. 4 weeks (After study drug or placebo administration)
3 secondary outcomes
AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)
Time frame: Approx. 5 months (Pre-dose to follow up)
aPTT will be measured via the kaolin-trigger method (clotting assay)
Time frame: Approx. 6 months (Before study drug or placebo administration to follow up)
Factor XI activity will be assessed with an aPTT-based coagulation test using FXI
Time frame: Approx. 6 months (Before study drug or placebo administration to follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1213790 and 0.9% sodium chloride solution in people with Renal Dialysis, run by Bayer at 15 sites in 4 countries.
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 4 inclusion and 5 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, United States, Belgium, Portugal. 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. Some participants in this study may receive a placebo. 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?
Number of major and CRNM bleeding events (time frame: Approx. 4 weeks (Before study drug or placebo administration)). The study lists 2 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 16 Mar 2022.