Kidney Transplantation
Conditions
Keywords
FR104, Renal transplant
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.
Interventions
DRUGFR104
FR104 treatment administration at day 0, day 14 then every 28 days until month 12
Sponsors
OSE Immunotherapeutics
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 6. Women of childbearing potential 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 \< 36 hours 11. Patients with French social security
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 | Description |
|---|---|---|
| Safety of FR104 - Adverse Events with a focus on infectious complications. In particular | Until Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on Renal function | Month 6 and Month 12 | Calculated glomerular filtration rate (CKD EPI) at each visit. |
| Efficacy on Biopsy-proven acute rejection (BPAR) | Month 12 | Acute cellular rejection seen on renal biopsy for cause up to Month 12 (per Banff criteria 2017) |
| Efficacy on clinically-treated acute rejections | Month 12 | Graft acute rejection up to Month 12. Number of AE related to treatment. Incidence and grade of rejection proven on Biopsy analysed after M12. |
| Efficacy on multiples rejection episodes | Month 12 | Rejection episodes up to Month 12. Number of rejection after M12. According to histology. Incidence of biopsy-proven rejection (by banff grade). |
| Efficacy on steroid-resistant episodes | Month 12 | Steroid resistant episodes up to Month 12. Corticoresistant rejection up to month 12 defined as non response at day 5-6 after steroid boluses. |
| Efficacy on graft survival | Month 12 | Renal dialysis or new kidney transplant up to Month 12 |
| Treatment failure time | Month 12 | Time to treatment failure up to M12 (Biopsy-proven acute rejection, Graft Loss or Death) |
| Evaluate the first Biopsy-proven acute rejection time | Month 12 | Time to the first Biopsy-proven acute rejection |
| Evaluate the appearance of Donor specific Antibodies | Month 12 | Appearance of Donor specific Antibodies |
| Efficacy on chronic allograft nephropathy | Month 12 | Chronic allograft nephropathy seen on renal biopsy for cause up to Month 12 |
Countries
France
Outcome results
None listed