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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a highly sensitized patient waiting for a kidney transplant.
Select...
I am between 15 and 75 years old.
Select...
I have received the pneumococcal vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in donor specific antibodies
Incidence of treatment related adverse effects of clazakizumab therapy
Secondary outcome measures
Change in Serum Creatinine
Incidence of ABMR episodes
Side effects data
From 2015 Phase 2 trial • 143 Patients • NCT020155205%
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: 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
~170
Find a Location
Who is running the clinical trial?
Stanley Jordan, MDLead Sponsor
3 Previous Clinical Trials
71 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a highly sensitized patient waiting for a kidney transplant.I am between 15 and 75 years old.I have had pregnancies, blood transfusions, or a kidney transplant.I cannot tolerate clazakizumab or similar medications.I have tested positive for hepatitis B or C.I have an active CMV or EBV infection confirmed by blood tests.I do not have active or latent TB, confirmed by a negative TB test.Your blood tests show a low count of certain white blood cells or platelets, or high levels of certain liver enzymes.I have received the pneumococcal vaccine.I am willing to use birth control as required if I or my partner can become pregnant.I am HIV-positive.I have or had Inflammatory Bowel Disease, Diverticular Disease, or a gastrointestinal perforation.I have not taken antibiotics for an infection in the last 6 weeks.You have tested negative for tuberculosis.I haven't had any live vaccines in the last two months.I have not had cancer in the past 5 years, except for certain skin cancers or cervical pre-cancer.I have received multiple organ transplants.
Research Study Groups:
This trial has the following groups:- Group 1: Clazakizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Might I be a good candidate for this research project?
"The ideal candidate for this medical study is somebody who suffers from kidney failure, is of childbearing age (15-75 years old), and has a history of pregnancies, blood transfusions, and/or renal transplants. Additionally, it is critical that the patient be willing to comply with all the requirements of the study."
Answered by AI
How does Clazakizumab compare to other drugs in its class?
"There are 4 clinical trials studying Clazakizumab, 1 of which is in its final Phase 3. Although the majority of research sites for Clazakizumab are located in Los Angeles, California, there are 149 locations running trials for this treatment globally."
Answered by AI
Are we still admitting people into this experiment?
"The clinical trial indicated on clinicaltrials.gov is not currently looking for participants, as the last update was over 3 months ago. That said, there are 354 other trials that are accepting patients at this time."
Answered by AI
Are participants in this trial restricted to a certain age group?
"According to the rules governing who can participate in this trial, the minimum age is 15 and the maximum is 75."
Answered by AI
How many test subjects are participating in this clinical trial?
"Although this study is not currently looking for new participants, it may in the future. The trial was first posted on February 27th, 2018 and was last edited on March 25th, 2022. If you are interested in other clinical trials, there are presently 350 studies actively searching for participants with kidney failure and 4 trials for Clazakizumab that are enrolling patients."
Answered by AI
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