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NCT04933747 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT04933747 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 26 participants.
The verdict
NCT04933747, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function. An open-label design was selected based on the objective nature of the primary endpoints (i.e., Pharmacokinetics parameter estimates based on measurement of iberdomide and M12 concentrations). Participants with severe renal impairment (RI), participants with kidney failure on intermittent hemodialysis (IHD), and participants with normal renal function are being included in the current study. Participants with severe RI and kidney failure participants will be matched to participants with normal renal function based on sex, age (approximately ± 10 years), and body mass index (BMI; approximately ± 30%).
Interventions
- DRUG Iberdomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2023-01-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04933747
The ClinicalTrials.gov registry entry for NCT04933747 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Iberdomide is the first listed.
NCT04933747 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04933747 about?
NCT04933747 is a clinical study titled "Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function". This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function. An open-label design was selected based on the objective nature of the primary endpoints (i.e., Pharmacokinetics parameter es...
What is the current status of trial NCT04933747?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2021-08-12. Estimated completion is 2023-01-23.
What interventions are being tested in trial NCT04933747?
The interventions under investigation include: Iberdomide (DRUG).
Who is sponsoring clinical trial NCT04933747?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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