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A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function | Clinical Trials | Clareo Health

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A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function

A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function

NCT04237831•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function

Detailed Description

Recruitment temporarily on hold due to COVID-19

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
•Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation
•No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor.
•Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation.
•Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study.
•Women and men must use highly effective methods of contraception for the duration of treatment

Exclusion Criteria

•History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity)
•Positive results for drugs abuse in urine/saliva
•Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study
•Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population
•Known previous exposure to BMS-986259

Locations (3)

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Prism Clinical Research

Saint Paul, Minnesota, United States

Key Dates

Start Date

February 26, 2020

Primary Completion Date

July 16, 2021

Completion Date

July 16, 2021

Last Updated

September 24, 2021

Enrollment

ACTUAL participants

Conditions

Renal Failure

Interventions

BMS-986259

DRUG

CAR-T Cell Therapy for Desensitization in Kidney Transplantation

NCT06056102

Kidney TransplantKidney Failure+1 more

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RECRUITING

Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula

NCT06297343

Renal Failure

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function

Inclusion Criteria

Exclusion Criteria

CAR-T Cell Therapy for Desensitization in Kidney Transplantation

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