Treg Therapy in Subclinical Inflammation in Kidney Transplantation

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.

Conditions

• Kidney Transplant
• Adult Living Donor Kidney Transplant Recipients
• Renal Transplant
• Living Kidney Donor

Interventions

BIOLOGICAL

Polyclonal Regulatory T Cells

Participants randomized to polyTregs group will receive a single infusion of 550 ± 450 x 10\^6 polyTregs.

DRUG

Everolimus

DRUG

Tacrolimus

DRUG

Mycophenolate mofetil

All enrolled participants will be on MMF (or MPA below) at the time of study entry at a minimum dose of 1000mg per day.

DRUG

Mycophenolic acid

All enrolled participants will be on MPA (or MMF above) at the time of study entry at a minimum dose of 720mg per day.

DRUG

Acetaminophen

650 mg acetaminophen, administered 30-60 minutes prior to infusion as pre-medication.

DRUG

Diphenhydramine

25-50 mg diphenhydramine intravenously or by mouth, administered 30-60 minutes prior to infusion as pre-medication.

PROCEDURE

Biopsy, Kidney

PROCEDURE

Blood Draw

PROCEDURE

Leukapheresis

PROCEDURE

IS regimen conversion

Conversion from Tacrolimus, a calcineurin inhibitors (CNI), to Everolimus, an mTOR inhibitor.

Sponsors & Collaborators

• Clinical Trials in Organ Transplantation

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Flavio Vincenti, MD · University of California at San Francisco

• Sindhu Chandran, MD · University of California at San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-20

Primary Completion

2023-08-04

Completion

2023-08-04

Countries

• United States

Study Locations