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Phase I/II Study of FR104 First Administration In Patient With Renal Transplantation: FIRsT Study

NCT04837092 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-15

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) of FR104 as well as its potential clinical effect on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.

Conditions

  • Kidney Transplantation

Interventions

DRUG

FR104

FR104 treatment administration at day 0, day 14 then every 28 days until month 12

Sponsors & Collaborators

  • OSE Immunotherapeutics

    collaborator INDUSTRY

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2025-04-14
Completion
2025-04-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837092 on ClinicalTrials.gov