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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Stanley Jordan, MD
Study ID
NCT03380377
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • Clazakizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 21, 2018
Status verified
Apr 2025
Primary completion
Apr 16, 2024
Completion
Apr 16, 2024

Study Design

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

Arms

  • Experimental: Clazakizumab (Anti-IL-6 Monoclonal)
    All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment.

Primary Outcome Measure

Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA Testing [ Time Frame: 12 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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