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NCT04046549 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT04046549: Completed Phase 2 study, sponsored by Amgen.
NCT04046549 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046549, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased, living unrelated or human leukocyte antigen (HLA) non-identical living related donor.
Primary Outcome
Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflamma
Interventions
- DRUG Thymoglobulin
- DRUG Methylprednisolone
- DRUG VIB4920
- DRUG Belatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2023-03-22 |
| Phase | Phase 2 |
What the finished NCT04046549 record still lists
NCT04046549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Thymoglobulin is the first listed.
NCT04046549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04046549 about?
NCT04046549 is a clinical study titled "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". The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased, living unrelated or human leukocyte antigen (HLA) non-identical living rela...
What is the current status of trial NCT04046549?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2019-10-30. Estimated completion is 2023-03-22.
What interventions are being tested in trial NCT04046549?
The interventions under investigation include: Thymoglobulin (DRUG), Methylprednisolone (DRUG), VIB4920 (DRUG), Belatacept (DRUG).
Who is sponsoring clinical trial NCT04046549?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04046549's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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