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Monoclonal Antibodies

Clazakizumab for Kidney Transplant Rejection

Phase 1 & 2
Waitlist Available
Research Sponsored by Stanley Jordan, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 15-75 years at the time of screening.
Pneumococcal vaccinated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new drug to treat people with antibody mediated rejection, which is a serious form of allograft rejection. Clazakizumab, an anti-IL6 monoclonal antibody, will be given monthly for six to twelve doses, and patients will have biopsies at 6 and 12 months to check for improvement.

Who is the study for?
This trial is for people aged 15-75 with chronic kidney transplant rejection, proven by biopsy and specific antibodies. They must understand the study, have no TB or HIV, not be pregnant or breastfeeding, use contraception if applicable, and be vaccinated against pneumococcus.Check my eligibility
What is being tested?
The trial tests Clazakizumab (an anti-IL6 antibody) on patients with kidney transplant rejection. Participants will receive monthly doses for six months; if improved, they continue up to a year. Biopsies at 6 and possibly 12 months check progress.See study design
What are the potential side effects?
Potential side effects of Clazakizumab may include reactions where the drug is injected, increased risk of infections due to immune system suppression, liver issues indicated by blood tests changes, and possible gastrointestinal complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 15 and 75 years old.
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I have received the pneumococcal vaccine.
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My biopsy shows chronic active antibody-mediated rejection and I have donor-specific antibodies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Donor specific antibody elimination based on luminex HLA testing
Stabilization of clinical features of cABMR via BANFF biopsy grading criteria.
Secondary outcome measures
Immunologic markers
Incidence of treatment-related adverse events
Serum creatinine

Side effects data

From 2015 Phase 2 trial • 143 Patients • NCT02015520
5%
HYPERURICAEMIA
5%
BRONCHITIS
5%
INJECTION SITE RASH
5%
HYPERTRIGLYCERIDAEMIA
5%
COUGH
5%
INJECTION SITE BRUISING
5%
INFLUENZA LIKE ILLNESS
5%
CONTUSION
5%
FATIGUE
5%
URINARY TRACT INFECTION
5%
HYPERCHOLESTEROLAEMIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clazakizumab (1 mg) + MTX
Clazakizumab (25 mg) + MTX
Clazakizumab (5 mg) + MTX
Placebo + Methotrexate (MTX)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Clazakizumab (Anti-IL-6 Monoclonal)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clazakizumab
2012
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Stanley Jordan, MDLead Sponsor
3 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Antibody Mediated Rejection
20 Patients Enrolled for Antibody Mediated Rejection

Media Library

Clazakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03380377 — Phase 1 & 2
Antibody Mediated Rejection Clinical Trial 2023: Clazakizumab Highlights & Side Effects. Trial Name: NCT03380377 — Phase 1 & 2
Antibody Mediated Rejection Research Study Groups: Clazakizumab (Anti-IL-6 Monoclonal)
Clazakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03380377 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to enroll new patients in this clinical trial?

"Right now, this study is not enrolling patients. However, it was first posted on February 21st, 2018 and last edited on March 25th, 2022. Additionally, there are 71 other trials that are accepting participants at the moment."

Answered by AI

Does this research opportunity extend to octogenarians?

"In order to be considered for this study, patients must fall between the ages of 15 and 75. There are 7 other clinical trials available for children under 18 and 71 additional options for seniors 65 and older."

Answered by AI

Who might be best suited for this type of clinical research?

"The prerequisites for this particular clinical trial are as follows: the patient must have a kidney transplant, be between the ages of 15 and 75, and experience organ rejection. So far, around 10 people have met these qualifications and have been accepted into the study."

Answered by AI

What other research exists on Clazakizumab's efficacy?

"There are currently 4 different clinical trials studying Clazakizumab. 1 of those is in Phase 3, while the others are still in earlier stages. The majority of these studies originate from Los Angeles, but there are 149 locations running investigations into this potential treatment."

Answered by AI
~0 spots leftby Jun 2024