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NCT05060991 · ClinicalTrials.gov registry record · Phase 4
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
A Phase 4 study of COVID-19 and Immunosuppression, sponsored by University of California, Davis.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05060991: Recruiting Phase 4 study of COVID-19 and Immunosuppression, sponsored by University of California, Davis.
NCT05060991 is a Phase 4 study of COVID-19 and Immunosuppression that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 50 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05060991, a Phase 4 study of COVID-19 and Immunosuppression, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second, or even third dose of mRNA vaccine. Treatment with antimetabolites was associated with poor vaccine response. The goal of this study is 1) examine whether transient immunosuppression reduction improves the immune response to a third dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.
Conditions Studied
Interventions
- DRUG Reduction in antimetabolite immunosuppression
Study Locations (1)
California
- University of California, Davis - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2025-12-24 |
| Phase | Phase 4 |
What NCT05060991 shows while recruiting
NCT05060991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which Reduction in antimetabolite immunosuppression is the first listed.
NCT05060991 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05060991 about?
NCT05060991 is a clinical study titled "Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients". Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second...
What is the current status of trial NCT05060991?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2021-09-24. Estimated completion is 2025-12-24.
What conditions does trial NCT05060991 study?
This clinical trial studies the following conditions: COVID-19, Immunosuppression, Vaccine Response Impaired.
What interventions are being tested in trial NCT05060991?
The interventions under investigation include: Reduction in antimetabolite immunosuppression (DRUG).
Who is sponsoring clinical trial NCT05060991?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05060991 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05060991's enrollment target sits among peer trials
50 245th of 298 higher than 50 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 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.
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