Treg Modulation With CD28 and IL-6 Receptor Antagonists

Summary

The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.

Conditions

• Living-Donor Kidney Transplant
• Kidney Transplant Recipients

Interventions

BIOLOGICAL

lulizumab pegol

25 mg subcutaneously (SC) on Day 1 post transplantation then 12.5 mg SC weekly through day 77 (Week 11)

BIOLOGICAL

antithymocyte globulin (rabbit)

Study participants are administered four doses of rabbit anti-thymocyte globulin, total dose 6 mg/kg given in divided doses on the day of transplantation and days 1-3.

DRUG

methylprednisolone

500 mg (IV) on Day 0 (day of transplantation), 250 mg (IV) on Day 1 and 125 mg (IV) on Day 2

BIOLOGICAL

tocilizumab

8 mg/kg (IV) on Day 2 post transplantation followed by 162 mg (SC) every 2 weeks through day 168 (Week 24)

DRUG

Prednisone

Beginning on Day 3 post transplantation, taken orally: 60 mg daily * Days 4 through 10: 30 mg daily * Days 11 through 17: 20 mg daily * Days 18 through 24: 10 mg daily * After Day 24: continued taper of dose to final maintenance dose of 5 mg, per protocol

DRUG

everolimus

Initial dose of 0.75 mg taken orally twice daily on Day 14 days after transplantation. Dose will be titrated to target trough levels 3-8 ng/mL.

BIOLOGICAL

belatacept

5 mg/kg (IV) every 4 weeks starting on Day 84 (Week 12) and continuing through Day 364 (Week 52)

DRUG

mycophenolate mofetil

mycophenolate mofetil is started no later than one day after transplant at 1000mg PO twice daily provided WBC count permits, staying on it until everoliumus level is within therapeutic range. Participants that do no tolerate everolimus can stay on or switch back to mycophenolate mofetil 1000 mg twice daily and remain in trial.

DRUG

mycophenolic acid

mycophenolic acid is started no later than one day after transplant at 720mg PO twice daily provided WBC count permits, staying on it until everoliumus level is within therapeutic range. Participants that do not tolerate everolimus can stay on or switch back to 720 mg twice daily of mycophenolic acid and remain in trial.

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Clinical Trials in Organ Transplantation

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Flavio Vincenti, M.D. · University of California San Francisco School of Medicine: Transplantation

• Sindhu Chandran, M.D. · University of California San Francisco School of Medicine: Transplantation

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-11

Primary Completion

2023-09-14

Completion

2023-09-14

FDA Drug

Yes

Countries

• United States

Study Locations