Phase I/II Study of FR104 First Administration In Patient With Renal Transplantation: FIRsT Study (NCT04837092) | Clinical Trial Compass
CompletedPhase 1/2
Phase I/II Study of FR104 First Administration In Patient With Renal Transplantation: FIRsT Study
France10 participantsStarted 2021-06-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 -
Exclusion criteria
✕. Recipient of a kidney from living donor
✕. Patient at high immunological risk of rejection as determined for assessment of anti-donor reactivity:
✕. Any retransplantation and combined transplantations
✕. ABO incompatible transplantation
What they're measuring
1
Safety of FR104 - Adverse Events with a focus on infectious complications. In particular
✕. 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