Renal ImpairmentPhase 1NCT06589713
Effect of Renal Impairment on Enpatoran Pharmacokinetics
A Phase 1 study testing Enpatoran in people with Renal Impairment, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Enpatoran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2024to 13 Apr 2026
- 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
- For Control Group 1 (Normal Renal Function):
- Medical history and physical examination without any ongoing clinically relevant findings as judged by the Investigator
- No clinically relevant findings (only minor deviations) in biochemistry, hematology, coagulation, and urinalysis examinations for the age of the participant, as judged by the Investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits
- For Group 2 (Impaired Renal Function):
- Medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof
- Chronic kidney disease
- For participants under medication, stable medication for at least 1 month
- Other protocol defined inclusion criteria could apply
Who cannot join
- History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant.
- History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
- History or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to Screening), or neuropsychiatric conditions
- History of serotonin syndrome
- Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening, which might interfere with the objectives of the study or the study procedures
- Other protocol defined exclusion criteria could apply
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: Phase 1, Open Label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Enpatoran in Male and Female Participants
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.
- Conditions
- Renal Impairment
- Being tested
- Enpatoran
- Keywords
- Renal impairment, Clinical pharmacology, Pharmacokinetics
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnpatoranDrug
Participants will receive a single oral dose of enpataron tablets once daily.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 1 (Normal Renal Function) | Experimental | Not described Receives: Drug: Enpatoran |
| Group 2 (Impaired Renal Function) | Experimental | Not described Receives: Drug: Enpatoran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) Plasma Concentrations of Enpatoran
Measured: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose
Secondary outcomes (2)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 35
Number of Participants with Abnormal Vital Signs, Laboratory Variables and 12-Lead Electrocardiogram (ECG)
Measured: Baseline and up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Sep 2024
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589713
- Sponsor's protocol ID
- MS200569_0051
- Other IDs
- 2024-513393-22-00
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open Label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Enpatoran in Male and Female Participants
- ClinicalTrials.gov ID
- NCT06589713
- Acronym / sponsor ID
- MS200569_0051
- Conditions
- Renal Impairment
- Keywords
- Renal impairment, Clinical pharmacology, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 19 Sep 2024 (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 assess the effect of renal impairment on the pharmacokinetics of enpatoran.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group 1 (Normal Renal Function) | Experimental | Drug: Enpatoran |
| Group 2 (Impaired Renal Function) | Experimental | Drug: Enpatoran |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Medical history and physical examination without any ongoing clinically relevant findings as judged by the Investigator
- No clinically relevant findings (only minor deviations) in biochemistry, hematology, coagulation, and urinalysis examinations for the age of the participant, as judged by the Investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits
- Medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof
- Chronic kidney disease
- For participants under medication, stable medication for at least 1 month
Key exclusion criteria (6 listed)
- History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant.
- History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
- History or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to Screening), or neuropsychiatric conditions
- History of serotonin syndrome
- Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening, which might interfere with the objectives of the study or the study procedures
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 |
|---|---|---|
| EnpatoranParticipants will receive a single oral dose of enpataron tablets once daily. | Drug | Control Group 1 (Normal Renal Function), Group 2 (Impaired Renal Function) |
Primary outcome
Pharmacokinetic (PK) Plasma Concentrations of Enpatoran
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose
2 secondary outcomes
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 35
Number of Participants with Abnormal Vital Signs, Laboratory Variables and 12-Lead Electrocardiogram (ECG)
Time frame: Baseline and up to Day 35
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 1 May 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
Related trials for Renal Impairment
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
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.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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 Enpatoran in people with Renal Impairment, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 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 8 inclusion and 6 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 1 May 2026. 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 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?
Pharmacokinetic (PK) Plasma Concentrations of Enpatoran (time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose). 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 1 May 2026.