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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

HS patients (cPRA≥50%) awaiting DD or LD kidney transplant on the UNOS list

Age 15-75 years at the time of screening

Must not have

Intolerability to clazakizumab or other IL-6 inhibitor therapies

Subjects who test positive for HBV by HBVeAg/DNA or HCV infection [positive Anti-HCV (EIA) and confirmatory HCV RIBA]

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to desensitize people with failed allograft transplants so that they may be eligible to receive another transplant.

Who is the study for?

This trial is for highly-HLA sensitized patients aged 15-75 awaiting a kidney transplant, who have had previous allograft failure, pregnancies, transfusions or transplants. They must be on the UNOS list with a cPRA≥50%, vaccinated against pneumococcus and TB-free. It excludes those intolerant to IL-6 inhibitors, pregnant or lactating women, HIV/HBV/HCV positive individuals, recent live vaccine recipients and those with certain infections or malignancies.

What is being tested?

The study tests Clazakizumab in patients needing desensitization before a kidney transplant. Participants will receive up to six monthly pre-transplant doses of Clazakizumab (25 mg), continuing post-transplant if successful. The treatment aims to improve chances of receiving an HLA incompatible renal transplant and reduce rejection.

What are the potential side effects?

Potential side effects of Clazakizumab may include reactions at the injection site, increased risk of infections due to immune system suppression, liver enzyme abnormalities which could indicate liver damage, blood disorders such as low platelet counts or neutrophil levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a highly sensitized patient waiting for a kidney transplant.

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I am between 15 and 75 years old.

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I have received the pneumococcal vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot tolerate clazakizumab or similar medications.

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I have tested positive for hepatitis B or C.

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I have an active CMV or EBV infection confirmed by blood tests.

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I have not taken antibiotics for an infection in the last 6 weeks.

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I do not have active or latent TB, confirmed by a negative TB test.

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I am HIV-positive.

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I have or had Inflammatory Bowel Disease, Diverticular Disease, or a gastrointestinal perforation.

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I haven't had any live vaccines in the last two months.

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I have received multiple organ transplants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in donor specific antibodies

Incidence of treatment related adverse effects of clazakizumab therapy

Secondary study objectives

Change in Serum Creatinine

Incidence of ABMR episodes

Side effects data

From 2015 Phase 2 trial • 143 Patients • NCT02015520

FATIGUE

INJECTION SITE BRUISING

HYPERCHOLESTEROLAEMIA

INJECTION SITE RASH

COUGH

HYPERURICAEMIA

INFLUENZA LIKE ILLNESS

URINARY TRACT INFECTION

BRONCHITIS

CONTUSION

HYPERTRIGLYCERIDAEMIA

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Methotrexate (MTX)

Clazakizumab (1 mg) + MTX

Clazakizumab (5 mg) + MTX

Clazakizumab (25 mg) + MTX

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ClazakizumabExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clazakizumab

2012

Completed Phase 2

~180

0 / 12Eligibility criteria met