Phase 1/2 study of FR104 first administration In patient with Renal Transplantation: FIRsT study

Phase 1

• Conditions: Kidney transplant; MedDRA version: 21.1Level: LLTClassification code 10051366Term: Kidney graft dysfunctionSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2020-000599-38-FR
• Lead Sponsor: ANTES CH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-12
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1)Male or female = 18 years old
2)Signed and dated written informed consent prior to any study procedure
3)First kidney transplantation
4)Willing and able to participate to the study
5)Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception during the clinical trial (oral contraception, implant or IUD) throughout the study period and for 90 days after the last dose of FR104(see EMA guidance on section 2.2.2)
6)WOCBP must have a negative urinary pregnancy test the day of transplantation
7)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
8)Recipient of a kidney from deceased donor
9)Recipient of a de novo kidney transplant able to start the immunosuppressive regimen at the protocol-specified time point
10)Recipients of a kidney with a cold ischemia time (CIT) < 36 hours
11)Patients with French social security
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1)Recipient of a kidney from living donor
2)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)
3)Any retransplantation and combined transplantations
4)ABO incompatible transplantation
5)HIV-positive, EBV-negative or suffering active viral hepatitis B (AgHbs positive excluded) or hepatitis C, syphilis serology- positive recipient
6)CMV negative recipients of CMV positive donors (R-D+)
7)Patient with known history of tuberculosis
8)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
9)A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components
10)Previous history of cancer (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured)
11)Pregnant woman or likely to become pregnant or nursing
12)Patient under guardianship or trusteeship
13)Patient participating in another interventional clinical trial
14)Live viral or bacterial vaccines/treatment agents given from 3 months prior to FR104 administration (12 months for BCG vaccine)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified