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Selective CD28 Blockade in Renal Transplant Recipients

NCT04903054 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-03-22

No results posted yet for this study

Summary

The aim of this study is to evaluate the safety and efficacy of lulizumab, a CD28-specific domain antibody (CD28 dAb), compared to tacrolimus, as the primary immunosuppressant in first-time renal transplant recipients.

Conditions

  • Kidney Transplantation
  • Renal Transplant Recipients

Interventions

BIOLOGICAL

Lulizumab

Lulizumab is a pegylated, humanized monovalent domain antibody construct that is specific for human cluster of differentiation CD28.

DRUG

Tacrolimus

Standard of Care: Renal transplant rejection prophylaxis.

BIOLOGICAL

Thymoglobulin®

Standard of Care: Renal transplant rejection prophylaxis.

DRUG

Methylprednisolone

Standard of Care: Renal transplant rejection prophylaxis.

DRUG

Mycophenolate Mofetil

Standard of Care: Renal transplant rejection prophylaxis.

DRUG

Prednisone

Standard of Care: Renal transplant rejection prophylaxis.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Christian P. Larsen, MD, DPhil · Emory Transplant Center, Emory University

  • Andrew B. Adams, MD, PhD · Emory Transplant Center, Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2022-09-22
Completion
2022-09-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04903054 on ClinicalTrials.gov