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

NCT04837092 | Completed Phase 1 DMC

• 1 other identifier: RC20_0007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

FR104; Renal transplant

Outcome Measures

Primary Outcomes (1)

• Safety of FR104 - Adverse Events with a focus on infectious complications. In particular

  Type, severity (grades 3 and 4 adverse effects)., number and percent of Adverse Events with a focus on infectious complications. In particular, the following cumulative incidences will be calculated: Incidence of bacterial, fungal, viral, or parasitic infection, incidence of new malignancies, lymphopenia, anemia, leucopenia, cytopenia or biochemical disturbances related to the study drug.

  Until Month 12

Secondary Outcomes (10)

• Efficacy on Renal function

  Month 6 and Month 12

• Efficacy on Biopsy-proven acute rejection (BPAR)

  Month 12

• Efficacy on clinically-treated acute rejections

  Month 12

• Efficacy on steroid-resistant episodes

  Month 12

• Efficacy on multiples rejection episodes

  Month 12

Study Arms (1)

FR104 Treatment

EXPERIMENTAL

Drug: FR104

Interventions

FR104 DRUG

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

FR104 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years old
• Signed and dated written informed consent prior to any study procedure
• First kidney transplantation
• Willing and able to participate to the study
• Women of childbearing potential must use appropriate method(s) of contraception during the clinical trial (oral contraception, implant or intrauterine device) throughout the study period and for 90 days after the last dose of FR104
• Women of childbearing potential must have a negative urinary pregnancy test the day of transplantation
• All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of FR104, whichever is longer
• Recipient of a kidney from deceased donor -
• Recipient of a de novo kidney transplant able to start the immunosuppressive regimen at the protocol-specified time point
• Recipients of a kidney with a cold ischemia time \< 36 hours
• Patients with French social security

You may not qualify if:

• Recipient of a kidney from living donor
• Patient at high immunological risk of rejection as determined for assessment of anti-donor reactivity:
• High TGI \>20% or Presence of pre-formed DSA with MFI\>500 (results 12 weeks prior to enrollment are acceptable if no blood transfusion or abortion occurred during this period)
• Any retransplantation and combined transplantations
• ABO incompatible transplantation
• HIV-positive, EBV-negative or suffering active viral hepatitis B (AgHbs positive excluded) or hepatitis C, syphilis serology- positive recipient
• CMV negative recipients of CMV positive donors (R-D+)
• Patient with known history of tuberculosis
• Uncontrolled concomitant infection or any other unstable medical condition (heart failure, severe liver disease, psychiatric disorders, substance abuse) that could interfere with the study objectives
• A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components
• Previous history of cancer (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured)
• Pregnant woman or likely to become pregnant or nursing
• Patient under guardianship or trusteeship
• Patient participating in another interventional clinical trial
• Live viral or bacterial vaccines/treatment agents given from 3 months prior to FR104 administration (12 months for BCG vaccine)

Sponsors & Collaborators

• Nantes University Hospital: lead
• OSE Immunotherapeutics: collaborator

Study Sites (1)

Blancho

Nantes, France

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: April 8, 2021
• Study Start: June 28, 2021
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)