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Daratumumab for Heart Transplant Rejection
Study Summary
This trial is testing a drug to see if it can lower HLA antibodies in people waiting for a heart transplant or who have developed antibody-mediated rejection after a transplant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am unable to understand and agree to the study's details.I have had a condition where my lymphocytes grow abnormally.I haven't had any cancer except for skin cancer in the last 5 years.I have had moderate to severe asthma in the last 2 years.I am unable to understand and give consent for treatment.I have a history of cancer.I have a history of HIV or hepatitis B/C.My lung function is less than half of what is expected for someone my age and size.I have a serious heart condition.I am not pregnant or have confirmed it with a test.My liver tests are within the required range.I have heart inflammation, poor heart function, and treatments haven't worked.I have not used daratumumab or similar drugs recently.I am on the list for both heart and liver transplants.
- Group 1: AMR Treatment Group
- Group 2: HLA Desensitization Group
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does the protocol for this experiment encompass elderly participants?
"In agreement with this medical trial's standards, the age range for potential enrolment is 18 years old to 80."
Are there any vacancies remaining in this research program?
"As per the information presented on clinicaltrials.gov, recruitment for this particular trial has closed as of April 11th 2022. The study was initially made available to participants on March 31st 2022 and is no longer recruiting patients; however there are 19 other medical trials searching for volunteers at present."
What is the ultimate aim of this clinical research?
"The principal objective of this 16-week experiment is to determine the effect of daratumumab therapy on Human Leukocyte Antibody (HLA) titers in resistant Antibody Mediated Rejection (AMR). Secondary assessments include changes in Cardiac Systolic Strain as observed by echocardiogram, Right Ventricular Systolic Pressure (RVSP) when measured with an approximate pulmonary arterial systole pressure device, and similar evaluations for HLA sensitized patients."
Are there any potential adverse effects associated with the usage of Daratumumab and hyaluronidase-fihj?
"After careful evaluation, our team at Power assigned Daratumumab and hyaluronidase-fihj a score of 2 as there is evidence to suggest it's safe but none that confirms its efficacy."
What criteria must potential participants meet in order to be accepted into this clinical trial?
"To be considered for this study, prospective participants must possess the antibodies associated with rejection and fall within the age range of 18 to 80. The medical trial is hoping to enrol 6 people in total."
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