Safety Pharmacokinetics and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
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- STATUS
- Recruiting
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- participants needed
- 42
-
- sponsor
- Sanofi
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 patients 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 patients awaiting kidney transplantation.
Description
The study will have a screening period of up to 28 days, a treatment period of up to 12 weeks, a site visit FUP of up to 26 weeks, and an extended FUP until study cutoff.
The study duration that involves site visit per participant (ie, screening, treatment, site visit FUP) will be approximately 42 weeks.
The study duration including extended FUP per participant will be approximately 78 weeks (depending when the participant is enrolled).
Details
| Condition | Disorder of immune system |
|---|---|
| Age | 18-70 years |
| Treatment | Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent, Ranitidine or equivalent, Diphenhydramine or equivalent, Methylprednisolone or equivalent, Montelukast or equivalent |
| Clinical Study Identifier | NCT04294459 |
| Sponsor | Sanofi |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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Study Definition
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