Phase I/II Study of FR104 First Administration In Patient With Renal Transplantation: FIRsT Study (FIRsT)
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|ClinicalTrials.gov Identifier: NCT04837092|
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : March 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: FR104||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of FR104, a Novel Antagonist Pegylated Anti-CD28 Fab' Antibody Fragment in de Novo Renal Transplant Patients|
|Actual Study Start Date :||June 28, 2021|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2024|
|Experimental: FR104 Treatment||
FR104 treatment administration at day 0, day 14 then every 28 days until month 12
- Safety of FR104 - Adverse Events with a focus on infectious complications. In particular [ Time Frame: 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.
- Efficacy on Renal function [ Time Frame: Month 6 and Month 12 ]Calculated glomerular filtration rate (CKD EPI) at each visit.
- Efficacy on Biopsy-proven acute rejection (BPAR) [ Time Frame: 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 [ Time Frame: 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 steroid-resistant episodes [ Time Frame: 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 multiples rejection episodes [ Time Frame: 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 chronic allograft nephropathy [ Time Frame: Month 12 ]Chronic allograft nephropathy seen on renal biopsy for cause up to Month 12
- Efficacy on graft survival [ Time Frame: Month 12 ]Renal dialysis or new kidney transplant up to Month 12
- Treatment failure time [ Time Frame: 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 [ Time Frame: Month 12 ]Time to the first Biopsy-proven acute rejection
- Evaluate the appearance of Donor specific Antibodies [ Time Frame: Month 12 ]Appearance of Donor specific Antibodies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837092
|Contact: Gilles BLANCHOfirstname.lastname@example.org|
|Contact: Gilles Blancho, PU-PH|