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NCT06723535CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
27 (actual)
First submitted
4 Dec 2024
Start date
7 Dec 2024
Primary completion date
16 Sept 2025
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT06723535

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 27
  • From 7 Dec 2024 to the primary completion date, 16 Sept 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).

Lab values

  • Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.

Other

  • Individuals who are of childbearing potential, breastfeeding, or currently pregnant.
  • Other protocol defined inclusion/exclusion criteria apply.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 84 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
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Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
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Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Orlando Clinical Research Center
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.