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Monoclonal Antibodies

Clazakizumab for Antibody Mediated Rejection (IMAGINE Trial)

Phase 3

Waitlist Available

Research Sponsored by CSL Behring

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

To be considered for determination of study eligibility, the biopsy and DSA analysis must be performed at least 2 months ± 2 weeks after the end of any prior treatment for acute antibody-mediated rejection (ABMR) or T-cell-mediated rejection (TCMR), in order to show continuing CABMR and presence of HLA DSA

Serologic evidence of circulating DSA to HLA. The local laboratory DSA results must be reviewed and confirmed by the central HLA reviewer during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to 8 years

Awards & highlights

IMAGINE Trial Summary

This trial is testing a new drug to see if it is effective and safe in treating patients who have had a kidney transplant.

Who is the study for?

This trial is for kidney transplant recipients aged 18-75 who are at least 6 months post-transplant and have chronic active antibody-mediated rejection (CABMR). Participants must show specific biopsy signs of CABMR, confirmed by a central pathologist, and have circulating donor-specific antibodies. Pregnant individuals or those with recent treatments for rejection, certain infections like TB or hepatitis, HIV, or multiple organ transplants other than kidney-pancreas are excluded.Check my eligibility

What is being tested?

The trial tests clazakizumab's effectiveness and safety against CABMR in kidney transplant patients. Clazakizumab is an anti-interleukin-6 monoclonal antibody designed to reduce inflammation caused by the body's immune response to the transplanted kidney.See study design

What are the potential side effects?

Potential side effects of clazakizumab may include reactions where the drug is injected, increased risk of infections due to immune system suppression, liver issues, changes in blood cell counts leading to fatigue or bruising easily, and possible interference with cholesterol levels.

IMAGINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My last treatment for rejection was at least 2 months ago, and I still have CABMR with HLA DSA present.

Select...

My blood test shows antibodies against a transplant.

Select...

My kidney rejection is ongoing and confirmed by biopsy and specific blood tests.

Select...

I am between 18 and 75 years old.

IMAGINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to composite all-cause allograft loss or irreversible loss of allograft function

Secondary outcome measures

Area under the concentration-time curve (AUC0-tau) at steady state of CSL300

Change in (Donor-specific antibodies) DSA titers and Mean fluorescence intensity (MFI) scores from Baseline to EOT

Change in Banff lesion grading score (2015 criteria [Loupy et al, 2017]) of pre-treatment to post-treatment (Week 52) kidney biopsies

+11 more

IMAGINE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ClazakizumabActive Control1 Intervention

Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 that is administered subcutaneously.

Group II: PlaceboPlacebo Group1 Intervention

Physiologic saline solution that is administered subcutaneously.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

CSL BehringLead Sponsor

194 Previous Clinical Trials

1,210,872 Total Patients Enrolled

2 Trials studying Antibody Mediated Rejection

83 Patients Enrolled for Antibody Mediated Rejection

ICON Clinical ResearchIndustry Sponsor

49 Previous Clinical Trials

15,022 Total Patients Enrolled

Study DirectorStudy DirectorCSL Behring

1,207 Previous Clinical Trials

489,330 Total Patients Enrolled

Media Library

Clazakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03744910 — Phase 3

Antibody Mediated Rejection Research Study Groups: Clazakizumab, Placebo

Antibody Mediated Rejection Clinical Trial 2023: Clazakizumab Highlights & Side Effects. Trial Name: NCT03744910 — Phase 3

Clazakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03744910 — Phase 3

Frequently Asked Questions

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

What is the FDA's current opinion of Clazakizumab?

"Clazakizumab has received a score of 3 in terms of safety. This is because clazakizumab is a Phase 3 trial, which means that while there is some data supporting efficacy, multiple rounds of data are needed to support safety."

Answered by AI

Are we still enrolling participants for this research project?

"This is correct. The information on clinicaltrials.gov says that this study is presently recruiting participants. The trial was initially posted on 10/14/2019 and was most recently edited on 10/27/2022. The clinical trial is recruiting for 350 participants across 66 sites."

Answered by AI

In how many different hospitals is this clinical trial being run?

"To limit the inconvenience to participants, this trial is currently recruiting from 66 sites that are situated close to major population centres. For example, there are locations in Iowa City, Philadelphia and San Antonio."

Answered by AI

How many people are participating in this clinical trial?

"The information available on clinicaltrials.gov does show that this particular trial is still open for recruitment. This research project was first announced on October 14th, 2019 and has been accepting applications since then. There are 66 different sites where people can be enrolled in the study, and the goal is to 350 total participants."

Answered by AI

For which patient population is this treatment option available?

"Patients that have antibody mediated rejection and are between 18-75 years old may be accepted into this study. Right now, the clinical trial has 350 available spots for patients."

Answered by AI

What other scientific research has been done on Clazakizumab?

"There are 4 clinical trials underway for Clazakizumab, with 1 in Phase 3. Although several of the clinical trials for Clazakizumab are based in Los Angeles, California, there are actually 149 locations running these trials."

Answered by AI