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

Launched by BRISTOL-MYERS SQUIBB · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BMS-986278 to understand how it affects people with different levels of kidney function. Specifically, the researchers want to see how the medication works in individuals with severe kidney impairment, those with end-stage kidney disease who are undergoing hemodialysis, and healthy volunteers with normal kidney function. The goal is to learn about the safety of the drug and how the body processes it in these different groups.

To be eligible for this study, participants must be between 18 and 80 years old and meet specific health criteria. For those with severe kidney impairment, they should have a certain level of kidney function and be medically stable. Participants with end-stage kidney disease must be on hemodialysis and have shown they are getting adequate treatment. Healthy volunteers need to have normal kidney function. Throughout the study, participants will undergo regular check-ups to monitor their health and how the medication is affecting them. This trial is currently recruiting participants, and it’s a chance to contribute to important research that could help improve treatments for kidney-related conditions.

Gender

ALL

Eligibility criteria

• 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.
• * 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).
• Exclusion Criteria:
• • 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.