Kidney Failure, ChronicPhase 1NCT06723535
A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis
A Phase 1 study testing BMS-986278 in people with Kidney Failure, Chronic and Healthy Volunteers, run by Bristol-Myers Squibb at 4 sites in United States.
Trial summary
The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Chronic, Healthy Volunteers, Renal Impairment
- What is being tested?
- BMS-986278
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Dec 2024to 19 Sep 2025
- 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.
- Severe Renal Impaired Participants:
- Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.
- Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.
- Participant must be medically stable for at least 1 month before study intervention administration.
- Participants with ESRD:
Show all 11Show fewer
- Participant has ESRD as defined by an eGFR < 15 mL/min at screening.
- Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening.
- Participant has demonstrated adequate hemodialysis measurements (at least 2 Kt/V measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening.
- Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute.
- Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation).
Who cannot join
- Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.
- Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).
- Individuals who are of childbearing potential, breastfeeding, or currently pregnant.
- Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Local Institution - 0002
Miami, Florida, 33147-4040
Local Institution - 0003
Miami, Florida, 33172
Local Institution - 0004
Orlando, Florida, 32808-7820
Orlando Clinical Research Center
Orlando, Florida, 32809-3017
About this study
Official title: An Open-Label, Single-Dose, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of BMS-986278 in Participants With Normal Renal Function, Participants With Severe Renal Impairment, and Participants With End-Stage Renal Disease on Intermittent Hemodialysis
The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.
- Being tested
- BMS-986278
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986278Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group A and C | Experimental | Not described Receives: Drug: BMS-986278 |
| Group B: Period 1 | Experimental | Not described Receives: Drug: BMS-986278 |
| Group B: Period 2 | Experimental | Not described Receives: Drug: BMS-986278 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to Day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: Up to Day 8
Secondary outcomes (18)
Number of participants with adverse events (AEs)
Measured: Up to 28 days following discontinuation of dosing
Number of participants with physical examination abnormalities
Measured: Up to Day 8
Number of participants with vital sign abnormalities
Measured: Up to Day 8
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Measured: Up to Day 8
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 8
Time of maximum observed concentration (Tmax)
Measured: Up to Day 8
Terminal elimination half-life (T-HALF)
Measured: Up to Day 8
Apparent body clearance (CLT/F)
Measured: Up to Day 8
Apparent volume of distribution of terminal phase (Vz/F)
Measured: Up to Day 8
Concentration of BMS-986278 in dialysate
Measured: Up to Day 8
Total amount recovered in dialysate (DR)
Measured: Up to Day 8
Total percent of administered dose recovered in dialysate (%DR)
Measured: Up to Day 8
Free fraction of unbound drug (Fu)
Measured: Up to Day 8
Unbound Cmax (Cmax_u)
Measured: Up to Day 8
Unbound AUC(0-T) (AUC(0-T) _u)
Measured: Up to Day 8
Unbound AUC(INF) (AUC(INF)_u)
Measured: Up to Day 8
Unbound CLT/F (CLT/F_u)
Measured: Up to Day 8
Unbound Vz/F (Vz/F_u)
Measured: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start7 Dec 2024
- Primary completion16 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723535
- Sponsor's protocol ID
- IM027-1014
- Status last verified
- Oct 2025
- First submitted
- 4 Dec 2024
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of BMS-986278 in Participants With Normal Renal Function, Participants With Severe Renal Impairment, and Participants With End-Stage Renal Disease on Intermittent Hemodialysis
- ClinicalTrials.gov ID
- NCT06723535
- Acronym / sponsor ID
- IM027-1014
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 9 Dec 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 severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A and C | Experimental | Drug: BMS-986278 |
| Group B: Period 1 | Experimental | Drug: BMS-986278 |
| Group B: Period 2 | Experimental | Drug: BMS-986278 |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.
- Severe Renal Impaired Participants:
- Participants with ESRD:
- Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute.
- Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation).
Key exclusion criteria (4 listed)
- Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.
- Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).
- Individuals who are of childbearing potential, breastfeeding, or currently pregnant.
- Other protocol defined inclusion/exclusion criteria apply.
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 |
|---|---|---|
| BMS-986278Specified dose on specified days | Drug | Group A and C, Group B: Period 1, Group B: Period 2 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to Day 8
18 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 28 days following discontinuation of dosing
Number of participants with physical examination abnormalities
Time frame: Up to Day 8
Number of participants with vital sign abnormalities
Time frame: Up to Day 8
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to Day 8
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 8
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 8
Terminal elimination half-life (T-HALF)
Time frame: Up to Day 8
Apparent body clearance (CLT/F)
Time frame: Up to Day 8
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to Day 8
Concentration of BMS-986278 in dialysate
Time frame: Up to Day 8
Total amount recovered in dialysate (DR)
Time frame: Up to Day 8
Total percent of administered dose recovered in dialysate (%DR)
Time frame: Up to Day 8
Free fraction of unbound drug (Fu)
Time frame: Up to Day 8
Unbound Cmax (Cmax_u)
Time frame: Up to Day 8
Unbound AUC(0-T) (AUC(0-T) _u)
Time frame: Up to Day 8
Unbound AUC(INF) (AUC(INF)_u)
Time frame: Up to Day 8
Unbound CLT/F (CLT/F_u)
Time frame: Up to Day 8
Unbound Vz/F (Vz/F_u)
Time frame: Up to Day 8
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 14 Oct 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986278 in people with Kidney Failure, Chronic and Healthy Volunteers, run by Bristol-Myers Squibb at 4 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 11 inclusion and 4 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 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Maximum observed concentration (Cmax) (time frame: Up to Day 8). 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?
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 14 Oct 2025.