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Immunosuppressant

lulizumab pegol for Kidney Transplant

Phase 1 & 2
Waitlist Available
Led By Flavio Vincenti, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 12 months post transplantation
Awards & highlights

Study Summary

This trial will study the safety of using a combination of drugs to prevent organ rejection in kidney transplant patients.

Eligible Conditions
  • Living Donor Kidney Transplant
  • Kidney Transplant Recipients

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post transplantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Proportion of participants who remain free of biopsy-proven acute T-cell mediated or antibody-mediated rejection as defined by Banff criteria
Other outcome measures
EXPLORATORY: Frequency of circulating T Regulatory Cells (Tregs)
EXPLORATORY:Alloreactive T cell frequency
EXPLORATORY:Expression of T cell checkpoint inhibition related genes
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: lulizumab pegol + novel ISRExperimental Treatment9 Interventions
lulizumab pegol + novel ISR: lulizumab pegol plus immunosuppressive regimen (anti-thymocyte globulin (rabbit), steroids,) belatacept, tocilizumab, and everolimus)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
belatacept
2017
Completed Phase 4
~280
mycophenolate mofetil
2000
Completed Phase 3
~1730
mycophenolic acid
2014
Completed Phase 4
~300
lulizumab pegol
2019
Completed Phase 2
~10
methylprednisolone
2004
Completed Phase 4
~1050
tocilizumab
2014
Completed Phase 4
~940
Prednisone
2014
Completed Phase 4
~2370
everolimus
2005
Completed Phase 3
~1550
antithymocyte globulin (rabbit)
2019
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,122 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,504 Total Patients Enrolled
Clinical Trials in Organ TransplantationNETWORK
17 Previous Clinical Trials
4,062 Total Patients Enrolled

Frequently Asked Questions

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

Does this study have an age limit?

"The age restriction for this trial is 18-70."

Answered by AI

What are some primary conditions that lulizumab pegol is indicated for?

"Lulizumab pegol is a common treatment for lung cancer. However, lulizumab pegol can also serve as an effective intervention against advanced carcinoid tumor, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

What is the participation rate of American hospitals in this experiment?

"So far, this trial has enrolled patients from Northwestern Memorial Hospital: Transplantation in Chicago, Illinois; University of Alabama School of Medicine: Transplantation in Birmingham, Alabama; and University of Colorado (UC) Health Transplant Center - Anschutz in Aurora, Colorado. There are 7 other locations where recruitment is still ongoing."

Answered by AI

Can new participants still join this experiment?

"Based on a review of the information available on clinicaltrials.gov, it appears that this trial is not currently recruiting patients. This study was initially posted on December 11th, 2019 and last updated on October 31st, 2020. There are 745 other trials actively looking for patients right now."

Answered by AI

Is lulizumab pegol a new medication?

"There are 730 ongoing clinical trials studying the efficacy of lulizumab pegol. Of these, 158 are Phase 3 studies. Most of the research for this medication is based in Philadelphia, but there are 23341 locations running trials worldwide."

Answered by AI

Are there any prerequisites for joining this research project?

"Up to 10 individuals between 18 and 70 years of age who have kidney disease may be accepted into this trial. In addition to meeting the general age and health requirements, participants must also use one of the following birth control methods for 12 months: Non-hormonal IUDs, Note: Female participants of childbearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for 12 months while on study drug regimen., Vasectomized partner, Male Participants-."

Answered by AI

What is the cap on how many people can sign up for this experiment?

"Unfortunately, this study is no longer looking for patients that meet the necessary requirements. Although, there are 15 other trials involving kidney cancer and 730 trials utilising lulizumab pegol that currently have open enrollment."

Answered by AI
~2 spots leftby Apr 2025