# Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

> **NCT04294459** · PHASE1,PHASE2 · TERMINATED · sponsor: **Sanofi** · enrollment: 23 (actual)

## Conditions studied

- Immune System Disorder

## Interventions

- **DRUG:** Isatuximab SAR650984
- **DRUG:** Acetaminophen (paracetamol) or equivalent
- **DRUG:** Ranitidine or equivalent
- **DRUG:** Diphenhydramine or equivalent
- **DRUG:** Methylprednisolone or equivalent
- **DRUG:** Montelukast or equivalent

## Key facts

- **NCT ID:** NCT04294459
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-06-18
- **Primary completion:** 2022-05-02
- **Final completion:** 2022-05-02
- **Target enrollment:** 23 (ACTUAL)
- **Why stopped:** Terminated due to non-safety reasons
- **Last updated:** 2025-09-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04294459

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04294459, "Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04294459. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*