Interleukin 6 Blockade Modifying Antibody-Mediated Graft Injury and Estimated Glomerular Filtration Rate (eGFR) Decline (IMAGINE)
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|ClinicalTrials.gov Identifier: NCT03744910|
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Antibody-mediated Rejection||Biological: Clazakizumab Drug: Normal saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||January 2028|
|Estimated Study Completion Date :||April 2028|
Active Comparator: Clazakizumab
350 subjects will have a 50/50 chance of being randomly assigned to receive a 12.5 mg subcutaneous (SC) injection once every 4 weeks (Q4W). 175 subjects will be treated with clazakizumab for up to 260 weeks.
Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6
Placebo Comparator: Placebo
350 subjects will have a 50/50 chance of being randomly assigned to receive a SC injection of normal saline once every 4 weeks (Q4W). 175 subjects will be treated with normal saline for up to 260 weeks.
Drug: Normal saline
- Incidence of all cause composite allograft loss [ Time Frame: Five years ]The aim of this study is to follow enrolled participants until 221 occurrences of all-cause allograft loss, defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m2 or death from any cause have been observed. The analysis will be a stratified log rank test of the effect of treatment on all-cause composite allograft loss, with stratification factors of dichotomized baseline eGFR (25-45 mL/min/1.73 m2 versus >45-65 mL/min/1.73 m2), baseline proteinuria, treatment for early (within 6 months of transplant) ABMR rejection episodes (yes/no), and treatment for late (greater than 6 months post transplant) ABMR rejection episodes (yes/no). Surviving subjects without allograft loss will be censored at the time of their last assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744910
|Contact: Head Project Management and Clinical Operationsfirstname.lastname@example.org|
|Contact: Head Regulatory Affairsemail@example.com|
|Study Chair:||Edward Chong, MBChB, MRCP||Vitaeris INC|