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NCT04294459 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT04294459: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT04294459 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04294459, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
Primary Objectives: * Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates. * Phase 2: To evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney transplantation. Secondary Objectives: * Phase 2: To characterize the safety profile of isatuximab in kidney transplant candidates. * To characterize the pharmacokinetic (PK) profile of isatuximab in kidney transplant candidates. * To evaluate the immunogenicity of isatuximab. * To assess the overall efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically import
Interventions
- DRUG Isatuximab SAR650984
- DRUG Acetaminophen (paracetamol) or equivalent
- DRUG Ranitidine or equivalent
- DRUG Diphenhydramine or equivalent
- DRUG Methylprednisolone or equivalent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-06-18 |
| Est. Completion | 2022-05-02 |
| Phase | Phase 1 |
Why NCT04294459 stopped before completion
NCT04294459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Isatuximab SAR650984 is the first listed.
NCT04294459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04294459 about?
NCT04294459 is a clinical study titled "Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation". Primary Objectives: * Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates. * Phase 2: To evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney transplantation. Secondary Objectives: * Phase 2: To characterize the safe...
What is the current status of trial NCT04294459?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-06-18. Estimated completion is 2022-05-02.
What interventions are being tested in trial NCT04294459?
The interventions under investigation include: Isatuximab SAR650984 (DRUG), Acetaminophen (paracetamol) or equivalent (DRUG), Ranitidine or equivalent (DRUG), Diphenhydramine or equivalent (DRUG), Methylprednisolone or equivalent (DRUG).
Who is sponsoring clinical trial NCT04294459?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04294459's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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