A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
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|ClinicalTrials.gov Identifier: NCT04046549|
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Allografts Rejection; Transplant, Kidney Transplant Rejection Kidney Transplantation||Drug: Belatacept Drug: VIB4920||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a Single-arm, Prospective, Open-label Pilot Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||June 17, 2022|
|Estimated Study Completion Date :||February 24, 2023|
Participants will be admitted to the transplant center for the administration of VIB4920 and belatacept and will be discharged on Day 3/4 at the discretion of the investigator. Participants will return to the study center to receive study drugs (VIB4920 and /or belatacept) weekly for 2 visits, then every 2 weeks for 5 visits, and then monthly for 9 visits for safety monitoring.
Belatacept Dose 1 will be administered intravenously on post-op Day 1, repeated on post-op Day 3 or 4, and at the end of Weeks 2, 4, 8 and 12; then Dose 2 every four weeks from Week 16 to Week 48.
VIB4920 Dose 1 will be administered intravenously on post-op Days 1, and 14, and at the end of Weeks 4, 6, 8 and 10; then will continue every four weeks from Week 12 to Week 48.
- Number of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24 [ Time Frame: Week 24 ]
- Incidence of Treated Biopsy-proven Acute Rejection (tBPAR), graft loss, death or loss to follow-up (LTFU) [ Time Frame: Week 12, 24, 48 ]
- Incidence of antibody-mediated rejection [ Time Frame: Week 12, 24, 48 ]
- Incidence of Treated Biopsy-proven Acute Rejection (tBPAR) [ Time Frame: Week 12, 24, 48 ]
- Incidence of Biopsy Proven Acute Rejection (BPAR) [ Time Frame: Week 12, 24, 48 ]
- Incidence of treated acute rejections [ Time Frame: Week 12, 24, 48 ]
- Proportion of Participants with De novo donor-specific antibodies (dnDSA) [ Time Frame: Week 12, 24, 48 ]Serum samples will be collected at the timepoints specified for de novo donor-specific antibodies (dnDSA) using solid phase (bead-based) assays.
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): NCT04046549
|Contact: Horizon Therapeuticsemail@example.com|
|United States, California|
|Keck Medical Center of USC||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Christian Romero firstname.lastname@example.org|
|Principal Investigator: Jim Kim, MD|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|United States, North Carolina|
|Duke University School of Medicine||Recruiting|
|Durham, North Carolina, United States, 27710|
|Study Director:||Gabor Illei, MD||Viela Bio|