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Immunomodulatory Agent
Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function
Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours following the last dose of iberdomide
Awards & highlights
No Placebo-Only Group
Summary
This trial tests iberdomide, a medication, in people with severe kidney problems, those on dialysis, and those with normal kidney function. It aims to see how the drug is processed differently in these groups.
Eligible Conditions
- Kidney Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 hours following the last dose of iberdomide
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours following the last dose of iberdomide
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Iberdomide Pharmacokinetics - AUC(0-T)
Iberdomide Pharmacokinetics - AUC(INF)
Iberdomide Pharmacokinetics - CLD
+13 moreSecondary study objectives
Incidence of Adverse Events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3: Participants with normal renal functionExperimental Treatment1 Intervention
Normal renal function, as defined by a creatinine clearance (Clcr) \> 90 mL/min estimated using the Cockcroft-Gault (C-G) equation, at screening.
Group II: Group 2: Participants with kidney failure who are on intermittent hemodialysis (IHD)Experimental Treatment1 Intervention
Kidney failure participants on intermittent hemodialysis (IHD)
Group III: Group 1: Participants with severe Renal Impairment (RI)Experimental Treatment1 Intervention
Severe Renal Impairment (RI), as defined by an eGFR \< 30 mL/min/1.73 m2 and not requiring dialysis, at screening
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-220
Not yet FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,157 Total Patients Enrolled
Alice Wang, MDStudy DirectorCelgene Corporation
1 Previous Clinical Trials
40 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,579 Previous Clinical Trials
3,387,594 Total Patients Enrolled
1 Trials studying Kidney Failure
48 Patients Enrolled for Kidney Failure