Clazakizumab for Antibody Mediated Rejection

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Antibody Mediated RejectionClazakizumab - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: Up to 5.5 years

Year 7
Change in (Donor-specific antibodies) DSA titers and Mean fluorescence intensity (MFI) scores from Baseline to EOT
Change in mean estimated glomerular filtration rate (eGFR) from Baseline to End of Treatment (EOT)
Change in spot urine albumin creatinine ratio (UACR) from Baseline to EOT
Incidence and time to loss of allograft function as defined by a 40% decline in eGFR from Baseline
Incidence of acute rejection episodes of T cell-mediated rejection(TCMR) and Antibody-mediated rejection (ABMR) from Baseline to EOT
Up to 21 days
Area under the concentration-time curve (AUC0-tau) at steady state of CSL300
Maximum concentration (Cmax, Cmax ss) of CSL300
Maximum serum concentration (Cmax, Cmax ss) of CSL300
Time of maximum concentration (Tmax, Tmax ss) of CSL300
Serum
Trough concentrations (Ctrough, Ctrough ss) of CSL300
Trough serum concentrations (Ctrough, Ctrough ss) of CSL300
Up to 5.5 years
Time to all-cause composite allograft loss
Up to 52 weeks
Change in Banff lesion grading score (2015 criteria [Loupy et al, 2017]) of pretreatment to posttreatment (Week 52) kidney biopsies
Change in Banff lesion grading score (2015 criteria) of pre-treatment to post-treatment (Week 52) kidney biopsies
Year 7
Incidence and time to all-cause composite allograft loss
Incidence and time to death-censored allograft loss
Overall patient survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Clazakizumab
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

350 Total Participants · 2 Treatment Groups

Primary Treatment: Clazakizumab · Has Placebo Group · Phase 3

Clazakizumab
Biological
ActiveComparator Group · 1 Intervention: Clazakizumab · Intervention Types: Biological
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Physiologic saline solution · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5.5 years

Who is running the clinical trial?

CSL BehringLead Sponsor
186 Previous Clinical Trials
407,396 Total Patients Enrolled
2 Trials studying Antibody Mediated Rejection
83 Patients Enrolled for Antibody Mediated Rejection
ICON Clinical ResearchIndustry Sponsor
45 Previous Clinical Trials
13,153 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,073 Previous Clinical Trials
476,136 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of CABMR and the presence of HLA DSA.
You have C4d staining in peritubular capillaries or medullary vasa recta.
You have serologic evidence of circulating DSA to HLA.
You are living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant.
You have morphologic evidence of chronic tissue injury, as demonstrated by TG.
You have evidence of current/recent antibody interaction with vascular endothelium, including 1 or more of the following.