Kidney transplant MedDRA version: 21.1 Level: LLT Classification code 10051366 Term: Kidney graft dysfunction System Organ Class: 100000004863
Conditions
Interventions
Product Name: FR104
Product Code: FR104
Pharmaceutical Form: Solution for infusion
Sponsors
NANTES CHU
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety of the FR104 up to 12 months;Secondary Objective: Evaluate the efficacy of the treatment up to 12 months •On the renal function at M6 and M12 •On Biopsy-proven acute rejection (BPAR) up to M12 •On clinically-treated acute rejections up to M12 •On steroid-resistant episodes up to M12 •On multiples rejection episodes up to M12 •On chronic allograft nephropathy up to M12 •On graft survival up to M12 •Evaluate the treatment failure time •Evaluate the first BPAR time (per Banff criteria 2017) •Evaluate the appearance of Donor specific Antibodies (DSA) •Long-term follow-up (1 year post-treatment);Primary end point(s): Type, severity, 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. ;Timepoint(s) of evaluation of this end point: This evaluation will be done at each visit up to M12 with a special focus on relevant grades 3 and 4 adverse effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The efficacy of the treatment will be evaluated by: •Calculated glomerular filtration rate (CKD EPI) at each visit. •Acute cellular rejection seen on renal biopsy up for cause up to M12 (per Banff criteria 2017) •Graft acute rejection up to M12 •Steroid resistant episodes up to M12 •Rejection episodes up to M12 •Chronic allograft nephropathy seen on renal biopsy for cause up to M12 •Renal dialysis or new kidney transplant up to M12 •Time to treatment failure up to M12 (BPAR, Graft Loss or Death) •Time to the first BPAR •Appearance of DSA •Long-term follow-up 1 year post-treatment to collect data (renal function, incidence of rejection, incidence of significant infections, incidence of new malignancies, occurrence of all suspected FR104 related adverse effects, patient survival and graft survival). ;Timepoint(s) of evaluation of this end point: •Calculated glomerular filtration rate (CKD EPI) at each visit up to M24 •Acute cellular rejection seen on renal biopsy for cause up to M12 •Graft acute rejection up to M12 •Steroid resistant episodes up to M12 •Rejection episodes up to M12 •Chronic allograft nephropathy seen on renal biopsy for cause up to M12 •Renal dialysis or new kidney transplant up to M12 •Time to treatment failure up to M14 (BPAR, Graft Loss or Death) •Time to the first BPAR •Appearance of DSA •Long-term follow-up at Year 2 post-transplantation | — |
Countries
France
Contacts
Public ContactLaetitia BERLY
NANTES CHU
Outcome results
None listed