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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 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04294459
The ClinicalTrials.gov registry entry for NCT04294459 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Isatuximab SAR650984 is the first listed.
NCT04294459 reports 0 study locations.
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.
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