TerminatedPhase 3

Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients

Stopped: Early stop for lack of efficacy/futility (at Interim analysis)

United States, Australia, Austria194 participantsStarted 2019-10-14

Plain-language summary

This trial investigates the efficacy and safety of clazakizumab \[an anti-interleukin (IL)-6 monoclonal antibody (mAb)\] for the treatment of CABMR in recipients of a kidney transplant.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-75 years.
. Living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant.
. Diagnosis of CABMR determined by kidney biopsy and the presence of HLA DSA using single-antigen bead-based assays. For eligibility, kidney biopsy must not be older than 12 months and DSA analysis must be performed no longer than 6 months prior to the start of Screening.

Exclusion criteria

. Morphologic evidence of chronic tissue injury, as demonstrated by transplant glomerulopathy (TG) (cg) \> 0). Biopsies without evidence of chronic tissue injury on light microscopy, but with glomerular basement membrane double contours on electron microscopy (cg1a) are eligible.
. Evidence of current/recent antibody interaction with vascular endothelium, including 1 or more of the following:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR)

Timeframe: From Baseline to Week 52

Number of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function

Timeframe: From Baseline to 4 years

Percentage of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function

Timeframe: From Baseline to 4 years

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)

Timeframe: Up to 4 years

Percentage of Participants With TEAEs, Serious TEAEs, and AESIs

Timeframe: Up to 4 years

Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)

Timeframe: From baseline up to 4 years

Number of Participants With Abnormal Laboratory Test Results

Trial details

NCT IDNCT03744910

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-08

Results submitted2025-04-03

View on ClinicalTrials.gov More Antibody-mediated Rejection trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-75 years.
. Living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant.
. Diagnosis of CABMR determined by kidney biopsy and the presence of HLA DSA using single-antigen bead-based assays. For eligibility, kidney biopsy must not be older than 12 months and DSA analysis must be performed no longer than 6 months prior to the start of Screening.

Exclusion criteria

. Morphologic evidence of chronic tissue injury, as demonstrated by transplant glomerulopathy (TG) (cg) \> 0). Biopsies without evidence of chronic tissue injury on light microscopy, but with glomerular basement membrane double contours on electron microscopy (cg1a) are eligible.
. Evidence of current/recent antibody interaction with vascular endothelium, including 1 or more of the following:

What they're measuring

Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR)

Timeframe: From Baseline to Week 52

Number of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function

Timeframe: From Baseline to 4 years

Percentage of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function

Timeframe: From Baseline to 4 years

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)

Timeframe: Up to 4 years

Percentage of Participants With TEAEs, Serious TEAEs, and AESIs

Timeframe: Up to 4 years

Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)

Timeframe: From baseline up to 4 years

Number of Participants With Abnormal Laboratory Test Results