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Carfilzomib + Belatacept for Kidney Transplant Compatibility (ADAPT Trial)
ADAPT Trial Summary
This trial is testing whether two drugs can make people less sensitized to kidney donors, making it easier to find a compatible donor.
ADAPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADAPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ADAPT Trial Design
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Who is running the clinical trial?
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- I am a woman who can have children and I have a negative pregnancy test.I am taking medications that increase my health risks.I have had an organ transplant.I understand the study and can give my consent.I have a history of certain infections or diseases.I am on the kidney transplant list with specific matching criteria.I have a history of certain medical conditions or treatments.I was recently hospitalized or treated for an infection.I am on dialysis for end-stage kidney disease.My latest TB test was negative or I've completed treatment for latent TB.
- Group 1: Cohort 2 (N=10 Subjects)
- Group 2: Cohort 1 (N=5 Subjects)
- 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
How many participants are helping to test this new treatment?
"That is correct. The clinicaltrials.gov website suggests that the trial is still recruiting patients. According to the information available, the study was originally posted on December 28th 2021 and was last updated on January 11th 2022. They are 15 patients needed at 1 site."
Are recruitment efforts for this experiment ongoing at the moment?
"The details published on clinicaltrials.gov show that this trial is ongoing and presently recruiting patients. The listing was first posted on December 28th, 2021 and last edited January 11th, 2022. They are looking for 15 individuals to participate at a single location."
Will elderly patients be able to participate in this research?
"The age range for patients that this trial can enroll is from 18 to 65. However, if a patient falls outside of that age bracket, there are still 3 trials for those under 18 and 97 trials for seniors above the age of 65."
Are there other examples of carfilzomib being used in a medical setting?
"At the moment, 98 different carfilzomib studies are underway. Of these, 15 are in Phase 3. The majority of research for this medication is taking place in Harrison, New york; although, there are 2692 total locations running clinical trials related to carfilzomib."
Who would be able to gain the most from this research?
"This clinical trial is recruiting 15 participants with highly sensitized prospective kidney transplant recipients aged 18 and 65. Most importantly, candidates should meet the following criteria: Current cPRA >98 percent (with >5 years of waiting time) awaiting deceased donor transplant, Individuals who meet all of the following criteria are eligible for enrollment as study subjects-."
What are the goals that we hope to achieve with this clinical trial?
"The primary outcome of this clinical trial is to assess the proportion of subjects who do not meet a stopping rule for safety and remain free of all of the safety events listed in the outcome description, through Week 20 post treatment initiation or until receiving a transplant, whichever occurs earlier. Secondary outcomes include Incidence of cytomegalovirus (CMV) infection within 20 weeks after starting treatment which is defined as CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present., Incidence of invasive fungal infections, mycobacterial"
Is this research novel in any way?
"Carfilzomib has been under investigation since 2010 when Merck Sharp & Dohme LLC. ran the first 4420 person study. After this Phase 3 drug approval, there have been 98 active trials in 740 different cities and 40 nations."
Which patients does carfilzomib help the most?
"Carfilzomib is often used to manage relapsed or refractory multiple myeloma. Additionally, carfilzomib has shown efficacy in treating steroid therapy, receptors, complement 3d, and therapeutic procedure patients."
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