Kidney Failure, ChronicPhase 1NCT07763418
A Study to Evaluate the Pharmacokinetics and Safety of Golcadomide in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function
A Phase 1 study testing Golcadomide in people with Kidney Failure, Chronic, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Golcadomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Sep 2026to 28 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must have severe renal impairment (RI).
- Participant must have end-stage renal disease (ESRD).
- Participant must be healthy male and female participants not of childbearing potential between 18 and 84 years of age (inclusive) with a BMI between 18 and 40 kg/m2, (inclusive) at screening.
Who cannot join
- Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
- Known or suspected active autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United States3 sites, 3 recruiting
- Recruiting
Arizona Clinical Trials - Chandler
Chandler, Arizona, 85225
Anita Kohli, Site 0003, 434-825-0921
- Recruiting
Panax Clinical Research
Miami Lakes, Florida, 33014
Robert Perry, Site 0002, 305-698-4500
- Recruiting
Orlando Clinical Research Center OCRC
Orlando, Florida, 32809-3017
Thomas Marbury, Site 0001, 407-257-3462
About this study
Official title: A Phase 1, Multi-center, Single-dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function
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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Golcadomide
- Keywords
- Golcadomide
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolcadomideDrug
Also called BMS-986369, CC-99282
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: Golcadomide |
| Group B | Experimental | Not described Receives: Drug: Golcadomide |
| Group C | Experimental | Not described Receives: Drug: Golcadomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to Day 44
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 44
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 44
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 44
Secondary outcomes (7)
Number of participants with adverse events (AEs)
Measured: Up to Day 60
Number of participants with serious adverse events (SAEs)
Measured: Up to Day 60
Number of participants with physical examination (PE) abnormalities
Measured: Up to Day 44
Number of participants with vital sign abnormalities
Measured: Up to Day 44
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 44
Number of participants with clinical safety laboratory abnormalities
Measured: Up to Day 44
Dialysate clearance of golcadomide from plasma (CLD)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start8 Sep 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763418
- Sponsor's protocol ID
- CA073-1033
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html