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Immunosuppression Adjustment for Improved COVID-19 Vaccine Response (ADIVKT Trial)

Phase 4
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether reducing immunosuppression drugs for a brief period may improve the effectiveness of a third dose of the COVID-19 mRNA vaccine in kidney transplant recipients, as well as assessing the safety of reducing immunosuppression before and after vaccination.

Who is the study for?
This trial is for kidney transplant recipients who have had a low response to COVID-19 vaccines, measured by antibody tests. They must be on specific immunosuppressive drugs and at least 6 months post-transplant. Participants need to consent to the study.
What is being tested?
The study is testing if reducing doses of certain immunosuppressant drugs can improve the body's immune response to an additional dose of a COVID-19 mRNA vaccine in those who've had weak responses previously.
What are the potential side effects?
Potential side effects may include increased risk of transplant rejection or infection due to reduced immunosuppression. The exact side effects will depend on how each individual reacts to changes in their medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immunosuppression reductionExperimental Treatment1 Intervention
Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine
Group II: Standard of careActive Control1 Intervention
No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
944 Previous Clinical Trials
4,755,925 Total Patients Enrolled
CareDxIndustry Sponsor
25 Previous Clinical Trials
15,441 Total Patients Enrolled
~0 spots leftby Dec 2024
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