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Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant

NCT03380962 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-24

No results posted yet for this study

Summary

Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.

Conditions

  • Kidney Failure, Chronic
  • End-Stage Renal Disease
  • Transplant Glomerulopathy
  • Transplant;Failure,Kidney
  • Kidney Transplant Failure and Rejection
  • Antibody-mediated Rejection
  • Kidney Transplant; Complications

Interventions

DRUG

Clazakizumab

All patients will receive clazakizumab 25 mg subcutaneous injections (monthly) for a maximum of 18 injections.

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
2018-02-27
Primary Completion
2025-08-30
Completion
2025-08-30
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 NCT03380962 on ClinicalTrials.gov