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Conditioning Regimen for Chimerism in Kidney Transplant
Study Summary
This trial is testing whether a new conditioning regimen is safe and can induce donor/recipient lymphohematopoietic chimerism, which may result in donor-specific unresponsiveness to the renal allograft.
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.Find a Location
Who is running the clinical trial?
Media Library
- My kidney disease, like FSGS, has a high risk of returning after a transplant.I am eligible for a kidney transplant from a donor who doesn't fully match my tissue type.I have had cancer before, but it was not skin cancer or early-stage cervical cancer.Your liver or blood clotting test results are more than twice the normal range.I have a genetic condition or family history that makes me more sensitive to radiation, or a physical shape that prevents safe radiation treatment.I currently have an infection.I am not allergic to Siplizumab, Fludarabine, Cyclophosphamide, tacrolimus, DMSO, MMF, or rituximab.You need to test negative for COVID-19 before the screening and also 2 days before the procedure.You have consistently low white blood cell or platelet counts.This is my first time receiving a transplant.I am between 18 and 60 years old.You have evidence of past exposure to the Epstein-Barr virus (EBV) in your blood.I have type 2 diabetes with an HbA1c level of 7 or higher and no severe complications.I have chronic kidney disease and am on dialysis.You have HIV, hepatitis B, or hepatitis C.Your PRA level was higher than 20% in the 6 months before the transplant.My kidney transplant is from a donor with a different blood type.Your lung function, measured by FEV1 or DLCO, is less than half of what is expected for someone your age and size.My heart's pumping ability is significantly reduced.I have previously received radiation therapy that was limited due to side effects.
- 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
Is geriatric participation permitted in this analysis?
"To meet the eligibility requirements for this clinical trial, applicants must be aged between 18 to 55. Furthermore, there are 6 studies available for younger patients and 171 trials specifically catered towards those over 65 years old."
Is enrollment for this trial currently accessible to potential participants?
"Affirmative. According to the data on clinicaltrials.gov, this trial is actively enrolling participants since its inception on September 1st 2021. The study requires 6 individuals from one medical centre and was last modified on December 16th 2021."
What level of risk does this treatment pose to individuals?
"Since this is a Phase 1 trial, meaning there are only preliminary data supporting safety and efficacy, the team at Power gave it an overall score of 1."
How many individuals are currently taking part in this clinical investigation?
"Indeed, clinicaltrials.gov attests that this trial is actively seeking participants. The initial post was on the 1st of September 2021 with the last edit being done on December 16th 2021; 6 patients from a single site are needed for completion."
Do I satisfy the prerequisites of this research project?
"This research is allowing six individuals with kidney failure, aged 18 to 55 years old, the opportunity to participate. Applicants must satisfy various criteria: be a possible recipient of an organ from an HLA mismatched donor; have chronic kidney disease or end-stage renal disease (ESRD) and receive dialysis treatments; already had at least one transplant before; and be either male or female in between 18 to 60 years of age."
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