Clazakizumab for Antibody Mediated Rejection
(IMAGINE Trial)

Recruiting in Palo Alto (17 mi)

+151 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CSL Behring

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests clazakizumab, a drug that blocks IL-6, in kidney transplant patients with chronic rejection. The goal is to see if it can reduce the immune system's attack on the transplanted kidney and improve its function. Clazakizumab is being tested for its potential to counteract rejection in kidney transplant patients.

Eligibility Criteria

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.

Inclusion Criteria

I received a kidney transplant more than 6 months ago.

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

The local pathologist's diagnosis must be reviewed by a central pathologist to confirm eligibility for entry into the study. Biopsies with other histopathologic changes (eg, BKV nephropathy or recurrent glomerulonephritis) may be eligible if concurrent CABMR changes (as detailed above) are present and determined to be the predominant cause of renal dysfunction

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Exclusion Criteria

I am HIV positive or have a history of HIV.

Seropositive for hepatitis B surface antigen (HBsAg)

Pregnant, breastfeeding, or unwillingness to practice adequate contraception

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Treatment Details

Interventions

Clazakizumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

Clazakizumab is already approved in United States for the following indications:

🇺🇸 Approved in United States as Clazakizumab for: