BMS-986278 for Kidney Failure

Recruiting at 7 trial locations

Overseen By Thomas Marbury, Site 0001

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Significant medical condition, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This study is for people with varying degrees of kidney function, from normal to severe impairment or end-stage renal disease requiring intermittent hemodialysis. It's designed to understand how these conditions affect the body's handling of the drug BMS-986278.

Inclusion Criteria

* 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.

1. Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.

2. Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of BMS-986278 to evaluate pharmacokinetics and safety

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986278

Trial Overview The trial is testing BMS-986278, focusing on how different levels of kidney health impact the drug's behavior in the body and its safety. The study will proceed in stages based on severity of renal impairment.

Participant Groups

Group I: Group B: Period 2 Experimental Treatment 1 Intervention

Group II: Group B: Period 1 Experimental Treatment 1 Intervention

Group III: Group A and C Experimental Treatment 1 Intervention

BMS-986278 is already approved in United States for the following indications:

Approved in United States as BMS-986278 for:

• Progressive Pulmonary Fibrosis (Breakthrough Therapy Designation)

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania