Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant

Part of paid clinical trials in Los Angeles, California.

Sponsor
Stanley Jordan, MD
Study ID
NCT03380962
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
15 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 27, 2018
Status verified
Mar 2025
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Clazakizumab
    All twenty patients will receive clazakizumab monthly. Patients will receive up to 6 doses pre-transplantation. If patients are transplanted during the study, they will then receive 6 doses of clazakizumab (monthly) and a 6 month protocol biopsy will be performed. Based on the biopsy results and clinical labs PI will determine if patients should continue monthly doses for up to another 6 doses and day 330 post-transplantation. Patients who received 12 post-transplant doses of clazakizumab will then undergo a 12 month protocol biopsy.

Primary Outcome Measure

Change in donor specific antibodies [ Time Frame: Up to 21 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Norko AmmermanLos AngelesCalifornia90048-

Find similar trials in Los Angeles, CA

By research site
Norko Ammerman· Los Angeles, CA

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