NCT04837092

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

A Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of FR104, a Novel Antagonist Pegylated Anti-CD28 Fab' Antibody Fragment in de Novo Renal Transplant Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	FR104	FR104 treatment administration at day 0, day 14 then every 28 days until month 12

Timeline

• Start date: 2021-06-28
• Primary completion: 2025-04-14
• Completion: 2025-04-14
• First posted: 2021-04-08
• Last updated: 2026-01-15

Locations

1 site across 1 country: France