COMPLETED

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

Conditions

Kidney Failure, Chronic Healthy Volunteers Renal Impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-12-07

Study Completion:2025-09-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06723535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 84 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * Severe Renal Impaired Participants: 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. 3. Participant must be medically stable for at least 1 month before study intervention administration. * Participants with ESRD: 1. Participant has ESRD as defined by an eGFR \< 15 mL/min at screening. 2. Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening. 3. 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).	* 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.

Inclusion Criteria

Exclusion 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.
* Severe Renal Impaired Participants:
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.
3. Participant must be medically stable for at least 1 month before study intervention administration.
* Participants with ESRD:
1. Participant has ESRD as defined by an eGFR \< 15 mL/min at screening.
2. Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening.
3. 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).

* 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.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0002

Miami, Florida, 33147-4040

United States

Local Institution - 0003

Miami, Florida, 33172

United States

Local Institution - 0004

Orlando, Florida, 32808-7820

United States

Orlando Clinical Research Center

Orlando, Florida, 32809-3017

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-07

Study Completion Date2025-09-19

Study Record Updates

Study Start Date2024-12-07

Study Completion Date2025-09-19

Terms related to this study

Additional Relevant MeSH Terms

Kidney Failure, Chronic
Healthy Volunteers
Renal Impairment