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Reduction in antimetabolite immunosuppression for Coronavirus (ADIVKT Trial)

Phase 4

Waitlist Available

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 6 weeks after receipt of 3rd dose mrna vaccine

Awards & highlights

ADIVKT 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.

Eligible Conditions

Coronavirus
Vaccine Response Impaired
COVID-19
Immunosuppression

ADIVKT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after receipt of 3rd dose mrna vaccine

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks after receipt of 3rd dose mrna vaccine

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after receipt of 3rd dose mrna vaccine for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline

Percentage of participants who achieve high-positive antibody titer

Secondary outcome measures

Acute rejection

Change in donor-derived cell free DNA from baseline

Change in glomerular filtration rate (GFR) from baseline

+2 more

ADIVKT 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

910 Previous Clinical Trials

4,706,941 Total Patients Enrolled

CareDxIndustry Sponsor

25 Previous Clinical Trials

15,421 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current recruitment quota for this research project?

"Affirmative, the clinical trial is still recruiting participants. According to its listing on clinicialtrials.gov, which was first posted September 24th 2021 and last updated February 7th 2022, 50 volunteers are needed from one location."

Answered by AI

What evidence exists that attests to the safety of decreasing immunosuppression with antimetabolites?

"In our assessment, this drug was rated 3 on the scale of 1 to 3 due to its Phase 4 classification, signifying that reduction in antimetabolite immunosuppression is government-approved."

Answered by AI

Are researchers currently recruiting for this investigation?

"Affirmative. Clinicaltrials.gov has this trial listed as actively enrolling patients, beginning on September 24th 2021 and last updated February 7th 2022. It is hoping to recruit 50 individuals across a single facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients

Aileen X Wang 2021. "Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05060991.

All > Kidney Transplant