A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis

Completed · Phase 1

Conditions studied: Kidney Failure, Chronic, Healthy Volunteers, Renal Impairment

In brief

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.

Key facts

Study ID

NCT06723535

Run by

Bristol-Myers Squibb

People needed

27

Starts

2024-12-07

Expected to finish

2025-09-19

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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).

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0002 — Miami, Florida, United States
• Local Institution - 0003 — Miami, Florida, United States
• Local Institution - 0004 — Orlando, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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