Treg Therapy in Subclinical Inflammation in Kidney Transplantation

Phase 1/2 Completed 32 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2016-09-20
Primary completion: 2023-08-04
Completion: 2023-08-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Maintenance vs polyTregs vs darTregs; p = 0.425; Fisher Exact NCT02711826 ↗

registry analysis (superiority test); Maintenance vs polyTregs vs darTregs; p = 0.700; Kruskal-Wallis NCT02711826 ↗

registry analysis (superiority test); Maintenance vs polyTregs; p = 0.201; Kruskal-Wallis NCT02711826 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	1.5 mg	Oral
Subject	Polyclonal Regulatory T Cells	Cell therapy	5.5e+08 cells	Intravenous
Background	Acetaminophen	Small molecule	650 mg	—
Background	Diphenhydramine	Small molecule	25 mg	Intravenous
Background	Diphenhydramine	Small molecule	50 mg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1000 mg	—
Background	Tacrolimus	Small molecule	—	—
Background	mycophenolic acid	Small molecule	720 mg	—

Indications

No indication recorded.