CompletedPhase 1

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

United States27 participantsStarted 2024-12-07

Plain-language 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.

Who can participate

Age range18 Years – 84 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

What they're measuring

Maximum observed concentration (Cmax)

Timeframe: Up to Day 8

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

Timeframe: Up to Day 8

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Timeframe: Up to Day 8

Trial details

NCT IDNCT06723535

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-16

View on ClinicalTrials.gov More Kidney Failure, Chronic trials

Who can participate

Age range18 Years – 84 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

What they're measuring

Maximum observed concentration (Cmax)

Timeframe: Up to Day 8

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

Timeframe: Up to Day 8

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Timeframe: Up to Day 8