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

Phase 3

Terminated

• Conditions: Antibody-mediated Rejection
• Interventions: Biological: Clazakizumab; Drug: Physiologic saline solution

• Registration Number: NCT03744910
• Lead Sponsor: CSL Behring

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-19
• Study Start: 2019-10-14
• Status Verified: 2024-04
• Primary Completion: 2024-04-08
• Study Completion: 2024-04-08
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clazakizumab	Clazakizumab	Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 that is administered subcutaneously.
Placebo	Physiologic saline solution	Physiologic saline solution that is administered subcutaneously.

Primary Outcome Measures

Name	Time	Method
Time to composite all-cause allograft loss or irreversible loss of allograft function	Up to approximately 8 years	Defined as time to first occurrence of any of the following components: * eGFR \< 15 mL/min/1.73 m2\*,; * return to dialysis\*,; * allograft nephrectomy,; * retransplantation,; * death from any cause, or; * a sustained (≥ 60 days) 40% decline in eGFR from Baseline. \*total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m2 AND / OR dialysis ≥ 60 days.; If the eGFR \< 15 mL/min/1.73 m2 is the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after ≥ 60 days from the first measurement.; The primary efficacy endpoint will be analyzed as part of the final analysis when at least 221 composite all-cause allograft loss or irreversible loss of allograft function events have occurred.

Secondary Outcome Measures

Name	Time	Method
Incidence of composite all-cause allograft loss or irreversible loss of allograft function	Up to approximately 8 years
Change in mean estimated glomerular filtration rate (eGFR) from Baseline to End of Treatment (EOT)	Baseline and up to approximately 8 years
Trough concentrations (Ctrough, Ctrough ss) of CSL300	Up to 21 days
Incidence and time to death-censored allograft loss	Up to approximately 8 years
Incidence of acute rejection episodes of T cell-mediated rejection(TCMR) and Antibody-mediated rejection (ABMR) from Baseline to EOT	Baseline and up to 8 years
Overall patient survival	Up to approximately 8 years
Time to composite all-cause allograft loss	Baseline and up to approximately 8 years
Incidence and time to irreversible loss of allograft function	Baseline and up to approximately 8 years
Change in spot urine albumin creatinine ratio (UACR) from Baseline to EOT	Baseline and up to approximately 8 years
Change in (Donor-specific antibodies) DSA titers and Mean fluorescence intensity (MFI) scores from Baseline to EOT	Baseline and up to approximately 8 years
Change in Banff lesion grading score (2015 criteria [Loupy et al, 2017]) of pre-treatment to post-treatment (Week 52) kidney biopsies	Up to 52 weeks
Maximum concentration (Cmax, Cmax ss) of CSL300	Up to 21 days
Area under the concentration-time curve (AUC0-tau) at steady state of CSL300	Up to 21 days
Time of maximum concentration (Tmax, Tmax ss) of CSL300	Up to 21 days

Trial Locations

Locations (138)

University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital); 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States

Keck Medical Center Of USC; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Kidney Transplant Research Program; 🇺🇸 Los Angeles, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

California Institute of Renal Research; 🇺🇸 San Diego, California, United States

North America Research Institute; 🇺🇸 San Dimas, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Kaiser Permanente; 🇺🇸 San Francisco, California, United States

Scroll for more (128 remaining)