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30 Participants NeededMy employer runs this trial

Golcadomide for Kidney Failure

Recruiting at 5 trial locations
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
Disqualifiers: Autoimmune disorder, Immunodeficiency, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the pharmacokinetics and safety of golcadomide (BMS-986369) in matched healthy participants with normal renal function, adult participants with severe renal impairment, and participants with end-stage renal disease.

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults either with severe kidney problems or end-stage kidney disease, as well as healthy adults with normal kidney function. Participants must meet health requirements set by the study and cannot join if they have other serious medical issues.

Inclusion Criteria

I have end-stage kidney disease.
I am a healthy adult, not able to have children, aged 18-84, with a BMI between 18 and 40.
I have severe kidney problems.

Exclusion Criteria

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
Other protocol-defined inclusion/exclusion criteria apply
I have an autoimmune disorder or a weakened immune system.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Golcadomide to evaluate pharmacokinetics and safety

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Golcadomide

Trial Overview

The study is testing how the drug golcadomide behaves in the body (absorption, breakdown, removal) and its safety in people with different levels of kidney function compared to those with healthy kidneys.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Group CExperimental Treatment1 Intervention
Group II: Group BExperimental Treatment1 Intervention
Group III: Group AExperimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

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