At a glance
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Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation (CTOT-21)
In Brief
A Phase 2 clinical trial evaluating Polyclonal Regulatory T Cells, Everolimus, and 9 other interventions for Kidney Transplant and 3 related conditions. Completed, enrolled 32 participants across 6 sites.
Detailed Summary
The purpose of this study is: * To see if polyTregs can reduce inflammation in a transplanted kidney. * To find out what effects, good or bad, polyTregs will have in the kidney recipient. * To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.
Study Details
Timeline
Interventions
Participants randomized to polyTregs group will receive a single infusion of 550 ± 450 x 10\^6 polyTregs.
All enrolled participants will be on MMF (or MPA below) at the time of study entry at a minimum dose of 1000mg per day.
All enrolled participants will be on MPA (or MMF above) at the time of study entry at a minimum dose of 720mg per day.
650 mg acetaminophen, administered 30-60 minutes prior to infusion as pre-medication.
25-50 mg diphenhydramine intravenously or by mouth, administered 30-60 minutes prior to infusion as pre-medication.
Conversion from Tacrolimus, a calcineurin inhibitors (CNI), to Everolimus, an mTOR inhibitor.