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CD28-specific domain antibody

Methylprednisolone for Kidney Transplant

Phase 2
Waitlist Available
Led By Andrew B. Adams, MD, PhD
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 month 12 and month 15 post transplantation
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of lulizumab to tacrolimus in kidney transplant patients.

Eligible Conditions
  • Kidney Transplant
  • Kidney Transplant Recipients

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12 and month 15 post transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 and month 15 post transplantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Estimated Glomerular Filtration rate (eGFR) (MDRD)
Secondary outcome measures
Change in Estimated Glomerular Filtration Rate (eGFR)
Cumulative Incidence of Serious Adverse Events
Days to Event: Antibody mediated rejection (ABMR)
+21 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lulizumab + SOCExperimental Treatment5 Interventions
N=27 participants will receive a loading dose of lulizumab on Day 0, the day of surgery. This will be followed by a maintenance dose administered on a weekly basis (weeks 1 through 26 post-transplant), followed by administration every two weeks (weeks 28 through 52 post-transplant). Method of administration: subcutaneously. Dose unit of measure: milligrams (mgs). Plus (+) Standard of Care (SOC) Regimen, per protocol- Renal transplant recipients will receive FDA-approved, immunosuppressive medications according to standard of care at Emory Transplant Center: Induction Thymoglobulin: Administered intravenously, dose unit of measure: mgs. Induction Methylprednisolone: Administered intravenously, dose unit of measure: mgs. Maintenance: Mycophenolate mofetil (MMF) administered by mouth twice daily, dose unit of measure: mgs. Maintenance: Beginning the day after methylprednisolone is completed, prednisone will be administered by mouth daily, dose unit of measure: mgs.
Group II: Tacrolimus + SOCActive Control5 Interventions
N=27 participants will receive tacrolimus initiated according to local standard of care and adjusted over time (maintenance) to target optimal trough levels measured in ng/mL: 0 to 6 months, 7 to 12 months and, thereafter, until completion of study participation. Dose unit of measure: mg/kg. Plus (+) Standard of Care (SOC) Regimen, per protocol- Renal transplant recipients will receive FDA-approved, immunosuppressive medications according to standard of care at Emory Transplant Center: Induction Thymoglobulin: Administered intravenously, dose unit of measure: mgs. Induction Methylprednisolone: Administered intravenously, dose unit of measure: mgs. Maintenance: Mycophenolate mofetil (MMF) administered by mouth twice daily, dose unit of measure: mgs. Maintenance: Beginning the day after methylprednisolone is completed, prednisone will be administered by mouth daily, dose unit of measure: mgs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte immunoglobulin (rabbit)
FDA approved
Methylprednisolone
FDA approved
Mycophenolate mofetil
FDA approved
Prednisone
FDA approved

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,132 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,514 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,915 Total Patients Enrolled

Frequently Asked Questions

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

In what clinical settings is lulizumab typically utilized?

"Lulizumab is the preferred treatment for scalp structure, but it can also be applied to thyroiditis, dermatitis, atopic, and ulcerative colitis."

Answered by AI

Are geriatric participants being incorporated into this research experiment?

"The cutoff age for this study is 70 years old, with 171 trials available to minors and 577 specifically tailored to individuals aged 65 and above."

Answered by AI

Are there any previous accounts of research into Lulizumab?

"As of today, 613 trials using Lulizumab are active, with 142 in the final Phase 3 stage. Of these studies, most are located within Philadelphia; however there exists a total of 18607 sites conducting research on this compound."

Answered by AI

Could I potentially be enrolled in this experiment?

"This clinical trial seeks 54 volunteers aged between 18 and 70, who have a kidney transplant. Additionally, female participants of childbearing age must demonstrate negative pregnancy results before randomization, while male participants should adopt an appropriate contraception method from the list provided by their physician. Furthermore, all applicants need to display both virtual or actual crossmatching with a Panel Reactive Antibody (PRA) score of 0% on admission sera."

Answered by AI

To what extent can Lulizumab be detrimental to patients?

"Taking into account the Phase 2 status of Lulizumab, our team at Power has assigned it a rating of 2 in terms of safety. This is due to limited data that confirms its security but no studies yet supporting efficacy."

Answered by AI

How many people are currently participating in this clinical research endeavor?

"Present recruitment for this trial has halted; it was first posted on October 1st 2021 and last updated on September 22nd 2021. However, 97 kidney-related studies and 613 trials involving lulizumab are still actively recruiting patients."

Answered by AI

Is this study still open to enrolling new participants?

"This trial has since been closed off to new participants. It was initially listed on October 1st 2021, and the last edit was made in September 22nd 2021. If you are searching for alternative studies, there are 97 trials actively recruiting patients with kidney issues and 613 clinical trials currently enrolling those hoping to receive Lulizumab."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Selective CD28 Blockade in Renal Transplant Recipients
2022. "Selective CD28 Blockade in Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903054.
~0 spots leftby Apr 2025
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