A Phase 1 interventional study of Golcadomide in Kidney Failure, Chronic, sponsored by Bristol-Myers Squibb. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 30 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Golcadomide
Drug: Golcadomide
Drug: Golcadomide
Specified dose on specified days
Also known as: BMS-986369, CC-99282
Maximum observed concentration (Cmax)
Time frame: Up to Day 44
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 44
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 44
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 44
Number of participants with adverse events (AEs)
Time frame: Up to Day 60
Number of participants with serious adverse events (SAEs)
Time frame: Up to Day 60
Number of participants with physical examination (PE) abnormalities
Time frame: Up to Day 44
Number of participants with vital sign abnormalities
Time frame: Up to Day 44
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 44
Number of participants with clinical safety laboratory abnormalities
Time frame: Up to Day 44
Dialysate clearance of golcadomide from plasma (CLD)
Time frame: Day 1
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.
Of 46 industry-sponsored phase 1 interventional studies under Kidney Failure, Chronic, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 3 months is below that.
Counting every sponsor, half of 67 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 1, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Golcadomide