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Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant

NCT03380377 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-06

Study results available
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Summary

Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy proven chronic antibody medicated rejection and/or donor specific antibody present at time of biopsy. Patients who qualify will be receiving clazakizumab (anti-IL6 monoclonal antibody) monthly x six doses. A protocol biopsy will be performed at 6 months and if improvement is seen, patients will continue another six doses for up to 12 months. For those completing 12 doses, there will be a 12 month protocol biopsy. For those who only received six doses, the next and last study visit will be at 12 months from enrollment. Total study duration is 12 months.

Conditions

  • Antibody-mediated Rejection
  • Kidney Transplant; Complications
  • Transplant Glomerulopathy
  • Transplant Glomerulopathy - Late Form
  • Transplant Glomerulopathy - Early Form
  • Kidney Transplant Rejection

Interventions

DRUG

Clazakizumab

Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.

Sponsors & Collaborators

  • Stanley Jordan, MD

    lead OTHER

Principal Investigators

  • Stanley Jordan, MD · Cedars-Sinai Medical Center Comprehensive Transplant Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2024-04-16
Completion
2024-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380377 on ClinicalTrials.gov